Supplier News 2015

Cololplast to Pay Millions to Settle Kickback Allegations
The FBI and DOJ accused Coloplast of paying kickbacks to five companies to help promote its products.Brian BuntzColoplast has had a rough year in 2015. In September, it announced plans to pay nearly nearly half a billion dollars to settle vaginal mesh ...

Does Samsung Have a 'Pickax' in Wearables Gold Rush?
While the Korean electronics giant continues to make its own wearables, it also plans to sell processors to makers of next-gen fitness tracking devices.Samsung is both making its own wearables while hoping to sell chips to competitors. Brian BuntzDesp...

FDA Debuts Plan to Improve Medical Device Warnings
Facing criticism from politicians and consumer advocates regarding its handling of medical device warnings, CDRH has announced draft guidance detailing how it will report possible medical device problems in the future.Brian BuntzLate in 2015, FDA commi...

FDA Wants to Share Emerging Signals
Marie ThibaultFDA is proposing a new policy to tell the public about emerging signals for medical devices in the postmarket setting. The agency has released draft guidance, "Public Notification of Emerging Postmarket Medical Device Signals" to describe...

Medtech Engineer Faces Jail Time for Theft of Trade Secrets
A former Boston Sci engineer was handed a one-year sentence for stealing plans for a medical device.Qmed StaffAaron Q. Khieu, a former Boston Scientific engineer, admitted that he stole the design for a Mustang Plus balloon catheter. In afederal court...

Next-Gen Google Glass Eyes Healthcare and Manufacturing
Having concluded that its Google Glass headset will not be a popular consumer item in the foreseeable future, Google is hoping healthcare and manufacturing institutions will boost the productivity of professionals ranging from doctors to assembly work...

Right Patient, Right Drug, Right Time: How Can Big Data Cure the Incurable?
Big data is only beginning to transform everything from R&D to clinical trials.Albert BourlaBourlaThis past fall, at the esteemed Milken Institute’s London Summit, I had the privilege of joining several colleagues on stage for a spirited discussion ab...

Rising STD Rates Spur Startups Toward New Point-of-Care Tests
Frank VinluanHoope's ring-shaped device uses a zap of electricity to block sensation from the device's needle stick for less painful STD testing. Despite healthcare efforts to clamp down on sexually transmitted diseases (STDs), infections have been on...

Teknor Apex to Show Off New Materials at MD&M West
The materials specialist Teknor Apex is seeing shifts in demands from medical device companies. Its product offerings at the MD&M West tradeshow will reflect these changes.Qmed StaffThe Medalist tubing sample kit from Teknor Apex is an examples of a p...

CDRH Makes Its New Year’s Guidance Resolutions
Marie ThibaultCDRH has mapped out its guidance priorities for the new year, publishing the "A-list" of medical device guidance documents it intends to publish in FY 2016 and the "B-list" of guidances it plans to publish if possible. In 2015, the center...

Samsung Wants to Make Wearables More Useful
FitBit has coasted to a $7.5 billion valuation by selling products that primarily track steps. Samsung has announced that it has developed a processor for wearables that can do much more: gauging body fat, skeletal muscle mass, heart rate, skin temper...

Theranos Data Tampering Allegations Could Prove Devastating
The Wall Street Journal interviewed former employees at blood-testing firm Theranos who maintain the company had deleted unflattering quality control data. If true, the news could be a healthcare counterpart to the Volkswagen emissions scandal. Kristo...

Why We Are Driving Toward Data-Driven Healthcare
Google Maps users now have more information at their disposal about street than most doctors do for their patients. But the healthcare industry is starting to adopt consumer-inspired data technologies, which could change everything from how medical de...

Duodenoscope Maker Updates and Validates Reprocessing Protocol
Marie ThibaultFUJIFILM Medical Systems, USA has released revised reprocessing instructions for one of its duodenoscope models.After a long year of negative headlines about duodenoscopes, one scope maker had an early holiday gift for its customers. FUJI...

Senate Medical Device Bill Raises Concerns
The degree to which lobbyists and FDA collaborated when drafting the text of the 21st Century Cures bill is peculiar, according to some legal scholars and consumer advocacy groups.  Brian BuntzAs early as next month, the Senate will consider passing "...

The Top 10 Medtech Crimes and Controversies of 2015
2015 was a year marked by several eyebrow-raising reports of medical-device-related cancer outbreaks and infections, fraud, and the murder of a handful of medical device professionals. We look back at the biggest controversies and crime stories of the...

Why I'm Not Celebrating the Medical Device Tax Holiday
Congress's two-year suspension of the medical device tax isn't a solution; it's a cop out.Jamie HartfordCongress gave the medtech industry an early Christmas present when it voted to temporarily suspend the medical device tax. Included in a $1.8 trill...

3DT’s PlasmaDyne surface treating system is revamped, trimmed-down, yet provides the same powerful adhesion to 3-D parts.
3DT's next generation atmospheric plasma surface treating system is ready for release.

Did Olympus Fail to Report Deadly Scope Problems?
An Olympus employee in the Netherlands found contamination in a TJF-Q180V duodenoscope as early as 2012, but the Japanese multinational for years did not raise alarms in the U.S., according to an LA Times investigation.Olympus' TJF-Q180V duodenoscope,...

How Nanotube 'Forests' Could Create Better Diagnostics
MIT engineers think the nanotube coatings could be used to trap hard-to-detect molecules.Qmed StaffThe patterned and cylindrical structure is comprised of carbon nanotubes. (Image courtesy of MIT)A coating made of "forests" of carbon and nanotubes can...

Sensors Step Up to Measure Pressures, Temperatures
Frank VinluanMinco's Three Channel is a validation system for diagnostics equipment, allowing the operator to determine whether the diagnostic is functioning properly. When medical devices need to determine when to cease or continue a function, or to ...

Toshiba Could Be Pulling Out of Medtech
The troubled Japanese multinational plans to sell at least a majority stake in its profitable healthcare business.Qmed StaffToshiba's roughly $3.5-billion-a-year makes diagnostic impaging equipment, such as the MRI machine shown above. (Image courtesy...

Your MD&M West To-Do List
Don't miss the world's largest medical design and manufacturing event, February 9-11, 2016, in Anaheim, CA.Jamie HartfordFrom February 9-11, 2016, thousands of medtech industry professionals will gather in Anaheim, CA, to attend Medical Design & Manuf...

10 Ways to Avoid Killing Your Innovation
Want to be the next big thing in medtech? Take these 10 lessons to heart.Chris NewmarkerOne of the most popular stories on Qmed this year came courtesy of Ted Harro, founder and president of Noonday Ventures, whose talk at Minnesota Medtech Week in No...

How Medtronic Is a Big Innovation Buyer
This year saw Medtronic on a spree to acquire new technologies after its $48 billion merger with Covidien.Chris NewmarkerTalking about acquiring innovation, Medtronic has been the prime example in 2015--engaging in a more than $1 billion spending spre...

Medtronic CEO: Digital/Mobile Tech Key to Evolution of Medtech
Omar Ishrak believes that digital health and mobile health technologies will enable the much-needed evolution of medtech. Arundhati ParmarDigital health and mobile health technologies have proliferated in 2015, and large medtech companies are also sit...

Omar Ishrak, Medtronic CEO, Unplugged
Omar Ishrak, CEO of Medtronic, is steering the largest pure-play medtech company at a time of great tumult and change in the industry. In a wide-ranging interview, Ishrak provides answers about the future of medtech and much more. Arundhati ParmarBack...

The 5 Most Important Medical Device Stories of 2015
From the relationship between innovation and medtech success to the major problems facing the industry, here are five significant themes from our most popular stories.Chris Newmarker          Medical device innovation--or potential lack of it--proved ...

The Secret to Innovation Driving Medtech Growth
Guess which medical device OEMs have been savviest at acquiring innovative technologies and getting them to market.Chris NewmarkerA funny thing happened on the way to producing a roundup of the five best performing medical device companies of 2015. It...

These Stories of Medtech Derring-do Will Inspire
Fretting over barriers stifling your innovation? Read these stories.Chris NewmarkerQmed readers this year were once again drawn to stories of necessity driving people to invention.For example, there was the story of Harry Paul (shown above), who has a...

Top Medtech News Stories of 2015
These were the biggest news stories of the year in medtech.2015 was a big year for the medtech industry. Mergers, partnerships, new regulatory approvals, and device controversies all made headlines here at MD+DI.Take a look back at the biggest medtech ...

Top Medtech News Stories of 2015: CMS Challenge
CMS Killed My $80M Venture-Backed StartupSonitus Medical raised $80 million from investors including Arboretum Ventures, Aberdare Ventures, and Medtronic, but a negative Medicare coverage decision shuttered the company.Read more here . . .            ...

Top Medtech News Stories of 2015: FDA on 3-D Printing
FDA's View on 3-D Printing Medical DevicesA CDRH representative said the agency views additive manufacturing as an enabling technology, just like CNC machining.Read more here . . .            [Image courtesy of OXFORD PERFORMANCE MATERIALS]Check out t...

Top Medtech News Stories of 2015: FDA's Dental Amalgam Stance
FDA Stands By Its Dental Amalgam Mistake The agency recently denied three petitions seeking to ban mercury-based dental amalgams, which some studies have linked to kidney damage and neurological disabilities and diseases.Read more here . . .          ...

Top Medtech News Stories of 2015: J&J and Google Partnership
J&J Hints at How Google Partnership Will Disrupt Surgical RoboticsJ&J is working with Google to make surgical robotic systems smarter, smaller, cheaper, and, ultimately, more accessible.Read more here . . .            [Image courtesy of INTUITIVE SURG...

Top Medtech News Stories of 2015: Medtronic's New Avatar
$50B Acquisition Complete, Medtronic's New Avatar LaunchesMedtronic and Covidien consummate their $49.9 billion deal and offer a subtle but profound change in the way the combined company will do business.Read more here . . .            [Image courtes...

Top Medtech News Stories of 2015: Medtronic's Transformation
Can Medtronic Still Be Called a Device Maker?Medtronic has just bought a Dutch clinic and research center focused on diabetes management. Can the company still be called just a device maker?Read more here . . .            [Image courtesy of MEDTRONIC]...

Top Medtech News Stories of 2015: Mega Deals Continue
J&J's $2B Cordis Sale, Bos Sci's $1.6B AMS Buy Continue Mega Deals TrendThe trend of mega deals in the medtech world continues with Johnson & Johnson and Boston Scientific announcing billion-dollar deals.Read more here . . .            [Image courtesy...

Top Medtech News Stories of 2015: Stryker's Strategy
Stryker: We are Playing a Different Offense Than ZimmerStryker executives believe that differentiated technology, not consolidation, is the path to win the future and the firm's MAKO's robotics platform is one such novel technology.Read more here . . ...

What You Need to Know About Medtech's Dirty Secrets
Superbug infections, questions about off-label promotion, and cybersecurity were all sources of concern in 2015.Chris NewmarkerThe medical device industry has a number of issues that should cause concern as it enters 2016.For example, there was a surg...

Top Medtech News Stories of 2015: Amazon Ready to Disrupt
How Amazon is Poised to Disrupt the Medtech IndustryHealthcare experts predict that Amazon will formally enter the healthcare marketplace in 2015 and the move will be disruptive.Read more here . . .           Continue to "Medtech Winners of 2015" [Ima...

Top Medtech News Stories of 2015: J&J Pipeline
J&J Beefing Up Device Product PipelineWill new product launches in the surgical, trauma, diabetes, and ophthalmology spaces be enough to turn around the company's sagging medical device sales in 2015?Read more here . . .            [Image courtesy of ...

Congress Gives Device Makers a Break from Excise Tax
Marie ThibaultThe votes are in and legislators in both the House and the Senate have passed a major tax deal that includes, among many other measures, a two-year suspension of the 2.3% medical device excise tax. The next stop for the bill is President ...

Laser Printing Images the Size of a Hair Follicle
A new laser printing technique now makes it possible to print high-resolution data and images with unprecedented quality at microscopic dimensions. Kristopher SturgisImage of the Mona Lisa, printed at just 50 micrometers long, roughly 10,000 times sma...

Medtech's Christmas Wish List
It would be a merry Christmas indeed if the medtech industry woke up to these things under the tree on December 25.Jamie HartfordChristmas is a magical time of year when you can ask for something you want and stand a reasonable chance of actually gett...

Medtronic CEO: The Biggest Threat to Medtech Is ...
Arundhati ParmarOmar Ishrak spoke with MD+DI in a wide-ranging interview in August, where the chief executive of the second-largest device firm in the world spoke about innovation, the hospital services business, risk-based purchasing contracts and mu...

Orchid Orthopedic Solutions Completes Acquisition of Cam Bioceramics Coating Facility in China
Holt, MI - Orchid Orthopedic Solutions (Orchid) completed its acquisition of the Cam Bioceramics coating facility and operations in China on December 15, 2015. Orchid is a worldwide leader in design and manufacturing for the orthopedic and med...

Smith & Nephew Stock Up Amid More Merger Rumors
Oh, the rumors. Smith & Nephew is enjoying some year-end recovery to its stock price amid more talk about Stryker acquiring it.Qmed StaffSmith & Nephew's stock shot up nearly 5% in value, to 1172 pence, on the London Stock Exchange on Friday, amid talk...

Why the Device Tax Suspension Is Just the Tip of the Iceberg
The medical device industry is getting more than just a suspension of the device tax in the huge spending and tax cuts package that has passed Congress.Chris NewmarkerThe U.S. Congress on Friday provided final passage for a roughly $1 trillion spending...

3-D Mammography Sends Hologic Skyrocketing
FDA-approved Genius 3D mammography systems played a major role in Hologic's stellar growth this year.Chris NewmarkerMammography innovation has been driving stellar growth for Hologic, which saw its stock value rise 46% through much of 2015. The Bedfor...

Cardio Societies Take Issue with Medicare Proposal for Watchman
Marie ThibaultA month after CMS released a tough proposal decision memo on reimbursement for Boston Scientific's Watchman left atrial appendage closure (LAAC) device, three major cardiology societies have pushed back on the proposal. The presidents of ...

Cardiology Pumps Up Terumo's Profits in 2015
The Japanese company's stock is up by nearly a third in value so far this year. Terumo, as with many medical device companies that fared well in 2015, has a strong cardiovascular business, having acquired some of their assets in this area from 3M in 1...

Edwards Stock Hits All-Time High This Year
Edwards Lifesciences' latest TAVR device, approved by FDA in June, includes a major design change to solve previous leakage issues. Chris Newmarker Edwards has certainly had meteoric growth since the beginning of 2014, with its stock rising from the m...

Interventional Cardiology Drives Boston Sci Growth
The Watchman left atrial appendage closure device and Lotus TAVR device are among the company's innovative cardiovascular products. Chris NewmarkerBoston Scientific CEO Michael Mahoney in recent years has been making good on his promise to turn around...

Medtech Losers of 2015: Valeant Pharmaceuticals
Valeant PharmaceuticalsPharma is increasingly encroaching on device makers’ territory, but that strategy may have backfired for one drug company that tried to jump on the bandwagon.In May, Canada-based Valeant Pharmaceuticals purchased Arizona-based P...

Medtech Losers of 2015: Women's Health Devices
Women's Health DevicesWomen’s health devices came under closer scrutiny this year.Power morcellators, in the headlines since 2013, chop up uterine tissue and may spread or advance undetected gynecologic cancers. This year, more insurers limited use of...

New Swabbable Needleless Injection Sites with T-Ports from Qosina
Qosina is pleased to announce the addition of three new t-port swabbable needleless injection sites, in stock and ready for immediate delivery.

Nipro Takes Off in 2015 Despite Asia's Economic Woes
Dialysis and cardio products are some of the Japanese company's major growth drivers.Chris NewmarkerDespite a deteriorating Chinese economy and a still-recovering Japanese economy, Nipro has managed to continue growth, boosting sales by 16% and profit...

Precise, flexible and easy to integrate: A new generation of Yb fiber lasers for marking plastics, metals and many other materials
With its Y-Series, FOBA Laser Marking + Engraving, a leader in industrial laser marking and engraving solutions, is introducing the next generation of high-precision fiber lasers for direct part and product marking. With their newly developed scan h...

The Top 5 Medical Device Companies of 2015
          2015 may go down as a comeback year for the cardiovascular device sector. It wasn't long ago that many professionals in the industry assumed the niche's glory days were over. But this year, many of the most successful device companies have b...

Why Google's Robots Could Drive New Surgical Possibilities
Johnson & Johnson and Alphabet Inc.'s new life sciences division, Verily Inc., have launched a new company to develop smaller and less expensive surgical robots.Nancy CrottiWhile Google has made a name for itself recently for innovating in the field o...

Congress Could Suspend Device Tax for 2 Years
The medical device industry must be on Santa's "nice" list.Chris NewmarkerThe U.S. Congress appears poised to suspend the 2.3% medical device excise tax for two years.The two-year suspension of the deal is part of the huge spending and tax-break packag...

Could This Super Fast Nanomotor Make a Difference?
UT Austin engineers are boasting a nanomotor with the speed of a jet airplane engine.Chris NewmarkerUT Austin researchers used AC and DC electric fields to assemble the nanomotor's parts one by one. (Illustration courtesy of UT Austin)It is less than ...

Device Tax May Be Suspended
Marie ThibaultIt may not be a complete repeal, but Congress is set to vote on a tax deal that includes a two-year suspension of the medical device tax.The legislation will go before a House vote Thursday and a Senate vote before the end of the week, ac...

For Home Healthcare Devices, the Power Supply Matters
Marie ThibaultThe ME60 Series, recently introduced by SL Power Electronics Corp., meets the latest electromedical safety standards for home healthcare devices.The push to bring medical devices and therapies into the home will likely only get stronger a...

Johnson & Johnson Hit with Extra $70 Million in Damages
The company's Ethicon subsidiary will seek to appeal the award in the case involving the Proximate PPH-03 surgical stapler.Nancy CrottiAn Oakland, CA, jury has awarded a California couple $70 million in punitive damages from Johnson & Johnson's Ethicon...

Medtech Losers of 2015
It has been a tough year for these companies and technologies.As 2015 draws to a close, we're looking back on what it meant for medtech. But for these companies and technologies, the end of the year can't come soon enough.Here's a look at the medtech ...

Medtech Losers of 2015: Duodenoscopes
nem-resistant enterobacteriaceae infections. It appears that in some cases, these scopes remained contaminated despite undergoing reprocessing.This year, FDA published a number of recommendations and finalized a guidance document on reprocessing reusa...

Medtech Losers of 2015: GI Dynamics
For GI Dynamics, makers of the CE-Marked EndoBarrier device therapy for obesity and type 2 diabetes, 2015 was full of challenges. The EndoBarrier device, an impermeable liner that is placed below the duodenal bulb in the first part of the small intest...

Medtech Losers of 2015: HeartWare
HeartWare, one of the two major makers of left ventricular assist devices sold in the United States, has had a tough year. The company announced a slew of recalls, including an alarm battery failure and the potential for damage to the driveline connec...

Medtech Losers of 2015: St. Jude Medical
St. Jude Medical probably thought it had a couple of homeruns with Nanostim, the world’s first commercially available leadless pacemaker, and the CardioMEMS HF system for remotely monitoring heart failure patients. But while there’s no doubt both of t...

Medtech Losers of 2015: Theranos
If there were a category for biggest loser on MD+DI’s annual list of winners and losers, California startup Theranos would likely take the dubious distinction.The Palo Alto company, whose much-vaunted young CEO Elizabeth Holmes aimed to upend the labo...

Medtronic CEO Welcomes Outcomes-Based Reimbursement
Arundhati ParmarStarting in April, hospitals in 67 geographic areas will receive bundled payments for any hip and knee replacements they do. If the outcomes are good, these hospitals can receive additional payments. If not, those hospitals will have t...

Is Off-label Promotion Out of Control?
The situation raises the question of whether more regulatory clarity is needed regarding the use of medical devices for off-label treatments.Qmed StaffOff-label promotion of medical products has been a central issue in many U.S. product liability laws...

5 Bold Predictions For Medtech in 2016
The times they are a changin'.2016 will be the first year that hospitals in 67 geographic areas of the country will begin to be paid a lump sum amount for hip and knee replacements as part of a five-year test of a new payment model from Centers for Me...

5 Medical Device Concerns That Made Us Worry in 2015
The end of the year is a great time to reassess, not just for individuals but for whole industries. In that spirit, here are five medical device stories that scream for lessons learned as we enter the new year.Qmed Staff          Deadly superbug outbr...

An Industry Takeover at FDA?
A recent controversy highlights the close relationship between FDA and industry, with some critics calling discussion of key legislation by the regulator and the regulated unethical. Jim DickinsonIf the Obama Administration and its improbable industry...

Burn Treatment Wins Expedited Access Designation
Marie ThibaultThe ReCell device from Avita Medical has earned FDA Expedited Access Pathway designation.FDA's Expedited Access Pathway (EAP) program is making good on its promise to accelerate the regulatory process for urgent medical devices. The agenc...

Digital Health Funding Reaches $4.3B in 2015 Matching 2014 Levels
Arundhati ParmarA funding report from Rock Health shows that digital health companies raised $4.3 billion in venture capital in 2015 matching, but not surpassing 2014 levels. A total of 278 companies raised that amount this year down from 294 startups...

Infusion Pumps and Cybersecurity
Are medical device companies too often ignoring or deprioritizing security problems?Qmed StaffThe theme of medical device cybersecurity has been making headlines for years but, in 2015, the topic received unprecedented attention.Security researcher Je...

Medtech Winners of 2015: Abiomed
The news has been nothing but positive this year for Abiomed, maker of a temporary ventricular assist device delivered percutaneously to the heart.Early in the year, Abiomed won HDE approval for its Impella RP System for right heart support. That was ...

Medtech Winners of 2015: Collaboration
CollaborationThere is growing recognition among medtech players that simply selling widgets to a hospital is akin to signing up for irrelevancy in the new healthcare paradigm. Collaboration is the order of the day.Medtronic is working with IBM Watson ...

Medtech Winners of 2015: Digital Health
This was the year digital health came into its own, maturing with viable business models and reimbursement coverage. Heeding calls for proof, digital health companies have started to show evidence of benefits for patients and healthcare costs.One such...

Medtech Winners of 2015: Patients
In September, FDA announced the creation of a Patient Engagement Advisory Committee made up of nine core voting members, plus a voting consumer representative and a nonvoting industry representative, that will advise the agency on “ issues relating to...

Medtech Winners of 2015: Risk-Sharing
Consider the risk Medtronic is undertaking with its Tyrx device, an absorbable antibacterial mesh sleeve that is wrapped around a cardiac device before it is implanted in a patient. People receiving implantable devices are at high risk for infection, ...

Medtech Winners of 2015: Stryker
The Kalamazoo, MI, company appears to have ironed out the integration challenges with the MAKO robotics-assisted surgical platform that hobbled it last year. In its third quarter, Stryker placed 17 MAKO systems with hospitals, compared with 13 in the ...

Medtech Winners of 2015: TMVR
Transcatheter mitral valve replacement therapy has yet to prove itself clinically, but it emerged this year as the next frontier for structural heart innovation and rapid deal-making.Edwards Lifesciences bought Irvine, CA-based CardiAQ for about $400 ...

Power Morcellation Gets Government Attention
The case of laparoscopic power morcellators is especially disturbing, because a widely used device turned out out to be especially dangerous.Qmed StaffLaparoscopic power morcellators, used for 24 years in the U.S. to slice up tissue during laparoscopi...

Superbug Infections Spread by Devices
While superbug infections are nothing new, there was a surge in interest and lawsuits related to them in 2015, thanks to deadly outbreaks associated with a particular type of endoscope called a duodenoscope.Qmed StaffIn early 2015, the Olympus TJF-Q18...

The Revolt Against Bayer's Essure
As with laparoscopic power morcellators, something appears not right when it comes to a device that has seen widespread use over the years.Qmed StaffBayer claims that only a small portion of the hundreds of thousands of women implanted with its Essure...

2015: The Year of True Medtech Collaboration
Arundhati Parmar2015 has embodied a true kumbaya moment in healthcare.Propelled by converging technologies and spurred on by the triple aim in healthcare, medtech companies have recognized the business value of collaboration. Throughout the year, they...

Consumers Worried About Safety of Connected Devices
Nancy CrottiThe threat of a direct cyberattack on patients’ implanted or wearable medical devices has been limited to TV shows, so far. In reality, that danger could be less than two years away, according to a medical device security expert from Price...

FREUDENBERG MEDICAL AWARDED BEST SUPPLIER TO THE MEDICAL TECHNOLOGY INDUSTRY

Indian Medtech Industry Seeing Healthy Growth
The government of India has agreed to separate the regulation of medical devices from that of pharmaceuticals, following longtime pressure from the device industry.Nancy CrottiIndia health ministry has agreed to separate schedule M III of India's Drug ...

Making Claims Data More Useful to Device Companies
Claims-based data can help improve patient outcomes and reduce future healthcare costs. Here's how medical device companies say they want to see claims data improved in order to be used more effectively.Marie ThibaultMedical device companies routinely ...

Medtech Winners of 2015
It has been a great year for these companies, technologies, and concepts.As 2015 draws to a close, we're looking back on what it meant for medtech. But for these companies, concepts, and technologies, the year was so good, they might not want it to en...

Medtronic CEO: Taking Risk Key to Value-Based Care
Arundhati ParmarThis year medtech companies began to dip their toes in risk-based purchasing contracts through which they are on the hook for demonstrating the effectiveness of their products.Medtronic, St. Jude Medical and Johnson & Johnson have publ...

Meet the AI Algorithm That Learns Like Humans Do
A new approach to AI programming yields a system that can recognize a handwritten character or symbol after seeing it just once, paving the way for more advanced and efficient AI systems. Kristopher SturgisBrenden Lake of New York University compares ...

Takeaways from the Neurotech Leaders Forum
Neurotechnology is at the cusp of becoming the future of healthcare.Dave JonesManaging pain without the use of opioids. Restoring functions to people with debilitating neurological disorders and injuries. Interacting with and educating your infant at ...

Venture Funding in Digital Health Holds Steady in 2015
2014 was a record year for digital health funding but 2015 has kept track. Brian BuntzLast year, the digital health sector accounted for an impressive 7% of all venture funding while the software sector attracted 40% of VC cash. This year, digital heal...

Sil-Pro Acquires Precision Machining Company
DELANO, Minnesota - Sil-Pro LLC, a leading provider of contract manufacturing and engineering services to the medical device industry, and Sil-Pro Machining Solutions (formerly MMI Precision) herein after referred to as Machining Solutions, a leadi...

Dow, DuPont Set for $130 Billion 'Merger of Equals'
The chemical giants have announced a plan to merge and then break apart into three separate entities. Qmed StaffDow and DuPont have agreed to merge in what the two companies term a "highly synergistic transaction" that will ultimately result in billion...

Medtronic CEO Wants To Capture Broader Diabetes Market
Arundhati ParmarMedtronic has high hopes for its diabetes business which saw revenue increase to $450 million in the quarter ended Oct. 30 from $430 million in the same period last year.While historically, the Irish medtech company has largely served ...

Medtronic Expands Use of Controversial Infuse Product
Medtronic's prized biologic was just granted approval for use with two additional indications. Having reached sales of close to $1 billion at its height, the combination product, originally approved as the Infuse Bone Graft/LT-Cage, has been mired wit...

The Chicken-and-Egg Problem in Developing Requirements for Complex First-Generation Medical Devices
Creating a meaningful product requirement that addresses both technical and user needs ultimately leads to a better end product and, in most cases, a quicker development time.Tor AldenOft-cited stats state that 80-90% of startups fail. The odds are po...

What Will Global Healthcare Revenue By Sector Look Like in 2016?
Arundhati ParmarFrost and Sullivan predicts that the global healthcare industry revenue will increase 6.9% to $1.68 trillion in 2016, up from $1.58 trillion this year. The consulting firm divided up the industry into six sectors - pharmaceuticals and ...

Boston Sci Has a Guidewire Problem
FDA posted 64 adverse events related to the company's Jagwire endoscopic guidewire last month, and 500 total since 2013. FDA also recently classified another Boston Sci guidewire recall as Class I. In addition, the company just announced a recall of ce...

Genentech Betting on a Device Approach to a Blockbuster Ophthalmic Drug
Arundhati ParmarGenentech's blockbuster, expensive and controversial ophthalmic drug Lucentis has been proved to be effective on treating wet age-related macular degeneration.When wet macular degeneration occurs, new blood vessels grow beneath the ret...

Infographic: Does Your Device Play Well with EHRs?
With the majority of U.S. physicians already using electronic health records (EHRs), demand for EHR software, hardware, and networking services has grown at a pace unmatched by most other medical technologies, including in the medical device sector. Q...

Intuitive Surgical: Watch Out For Google & J&J's New Kid on the Block
Arundhati ParmarJohnson & Johnson on Thursday formalized its March announcement that it was going to collaborate with Google Life Sciences (now called Verily) to develop advanced surgical solutions, by creating a new company called Verb Surgical.Verb ...

New Swabbable Needleless Injection Sites with Barbs from Qosina
Qosina is pleased to announce the addition of three new barbed swabbable needleless injection sites.

Programming Red Blood Cells to Carry Drugs
A new startup looks to tackle hard-to-treat genetic disorders and diseases through genetically engineered red blood cells.Kristopher SturgisThe new technology, unveiled by recent startup Rubius, could serve as a platform for a host of new therapies th...

Could This New Sensor Help with Eye Injuries?
The sensor offers the potential to quickly determine the severity of eye injuries at accident sites and remote areas.Nancy CrottiThe new sensor determines eye injury severity by detecting differences in vitamin C concentration in fluids that leak from...

FDA Commissioner Nomination Is Now on Hold
Robert Califf, MD, is now facing questions for his handling of a clinical trial and his role approving genetically modified salmon. Qmed StaffRobert Califf, MD, sat through a nomination hearing on November 17. Image courtesy of C-Span. The questions o...

Global Wearable Medical Devices Market To Grow to $17B by 2022
A November market research report pegs the global wearable medical devices market to reach $16.8 billion by 2022. That is up from $3.5 billion in 2014.  Not surprisingly, the Diagnostics & Monitoring segment of the overall wearables market commanded t...

Medtronic CEO: Hospital Services Play is About Changing Patient Outcomes
In August, the chief executive officer of Medtronic, the world's second-largest public medtech company by revenue, sat down for a wide ranging interview with MD+DI - everything from accountable care and risk-based contracts, to globalization and vario...

Ready or Not: Patient-Centered Device Development Is Here
How can medical device developers incorporate patient preference information into their device designs and studies?Joel V. Brill, MD, FACP, AGAFOver the last several years, FDA has taken “patient-centered” medicine to a whole new level, developing a p...

Why the Future of Disease Diagnosis Needs Engineers
Engineers are needed to build new diagnostic devices to truly get at the cause of disease, says pioneering cellular biologist Jamey Marth.Chris NewmarkerWhat about the role played by molecules other then nucleic acids, and the proteins they help creat...

9 Medical Technologies Poised to Explode in 2016: 3-D Tomographic X-Ray
3-D Tomographic X-RayThree-dimensional digital tomosynthesis has revolutionized mammography and is now poised to spread to other applications, such as orthopedics.A third imaging modality poised for a breakthrough in 2016 is 3-D tomographic x-ray. Ove...

9 Medical Technologies Poised to Explode in 2016: 7-T MRI
7-T MRISiemens's Magnetom Terra 7-T MRI system for research launched in May 2015.In the realm of magnetic resonance (MR) imaging, 7-T systems are starting to emerge from the lab after many years of 3-T MR being the most advanced generation of systems ...

9 Medical Technologies Poised to Explode in 2016: Clinical-Grade Wearables
Clinical-Grade WearablesiRhythm Technologies's Zio XT Patch can be worn for up to 14 days to provide continuous cardiac monitoring.Much maligned for tracking trivial metrics like steps and sleep, wearables could finally find meaningful clinical applic...

9 Medical Technologies Poised to Explode in 2016: Endocardial Left Atrial Appendage Closure Devices
Endocardial Left Atrial Appendage Closure DevicesBoston Scientific's Watchman left atrial appendage closure device won FDA approval in 2015.Another technology we’re likely to hear a lot more about is endocardial left atrial appendage (LAA) closure dev...

9 Medical Technologies Poised to Explode in 2016: Transcatheter Heart Valve Repair and Replacement
Transcatheter Heart Valve Repair and ReplacementMedtronic won approval for its CoreValve Evolut R transcatheter aortic valve replacement product in 2015.Transcatheter valve therapies—specifically transcatheter aortic valve replacement and transcathete...

Google's Ambitious New Healthcare Biz Is Hiring
Google's foray into the life sciences has grown into a sister spin-off company, with details continuing to come out about new technologies in the works.Chris Newmarker"Imagine a chemist and an engineer and a doctor and a behavioral scientist, all work...

How Electronics Could Revamp the Humble Bandage
A stretchy, adhesive bandage that makes use of temperature sensors and LED lights could be the world's first "smart band-aid." The technology could also be useful for prosthetic and mobile health applications.  Kristopher SturgisLittle has changed wit...

In Which Life Sciences & Health Startups Did Google Ventures Invest in 2015?
Life sciences and health are the most active areas for investment at Google Ventures. What startups in that industry did the venture arm of Alphabet fund in 2015?Arundhati ParmarGoogle Ventures is going to start off 2016 with $2.4 billion under manage...

What Life Sciences & Health Startups Did Google Ventures Invest in 2015? (Alector)
Name: AlectorLocation: San Francisco, as part of QB3 IncubatorWhat it Does: Developing immuno-modulatory therapies for Alzheimer’s disease, dementia and other neurodegenerative disorders.GV Participation: New investor in $32 million Series C round. GV...

What Life Sciences & Health Startups Did Google Ventures Invest in 2015? (Collective Health)
Name: Collective HealthLocation: San Mateo, CaliforniaWhat it Does: Software and services company that uses to data to modernize employer-based health insurance and combines medical, dental pharmacy and vision benefits in one platform. Insurance compa...

What Life Sciences & Health Startups Did Google Ventures Invest in 2015? (Editas Medicine)
Name: Editas MedicineLocation: Cambridge, MassachusettsWhat it Does: Uses genome editing, which allows sequence-targeted modification of DNA to potentially switch off or modify disease-creating genes to create new class of genomic medicine.GV Particip...

What Life Sciences & Health Startups Did Google Ventures Invest in 2015? (PatientPing)
Name: PatientPingLocation: BostonWhat it Does: Provides real-time notifications or "pings" to providers when patients receive care across the care continuum inside the PatientPing network. Currently there are more than 11,000 providers in the network ...

What Life Sciences & Health Startups Did Google Ventures Invest in 2015? (Zephyr Health)
Name: Zephyr HealthLocation: San FranciscoWhat it Does: Developed the Illuminate data analytics software solution to accelerate time to market for drugs, devices and diagnostics.GV Participation: New investor in $17.5 million Series C round. GV Invest...

What Life Sciences & Health Startups Did Google Ventures Invest in 2015?(Spruce)
Name: SpruceLocation: San FranciscoWhat it Does: Developed the Spruce dermatology app through which skin conditions can be diagnosed and treated by a board certified dermatologists in 24 hours for a price of $40. Consumers in 17 states including Calif...

7 Star Wars Lessons for Medtech That Would Make Yoda Proud
Image from PixabayMuch you can learn from the science fiction saga when it comes to creating great medical devices. "Do. Or do not. There is no try."Brian Buntz and Chris NewmarkerThe new Star Wars: The Force Awakens should hopefully not "suck," as di...

9 Medical Technologies Poised to Explode in 2016
No one can predict the future, but every year around this time, we ask medtech experts to give it their best shot. Here are the technologies they expect we’ll be talking about in 2016. Learn about emerging medical technologies at the MD&M West confere...

9 Medical Technologies Poised to Explode in 2016: Handheld Ultrasound
Handheld UltrasoundPhilips's app-based Lumify ultrasound system pairs with a smartphone or tablet.In 2016, Frost & Sullivan transformational health principal analyst Nadim Daher says a number of imaging modalities will start to come into their own.“In...

9 Medical Technologies Poised to Explode in 2016: Liquid Biopsy
Liquid BiopsyLiquid biopsy, a less-invasive alternative to conventional biopsy, analyzes blood for circulating tumor cells to detect cancer.Liquid biopsy, which eschews conventional, invasive tissue biopsies in favor of a blood test that’s analyzed fo...

9 Medical Technologies Poised to Explode in 2016: Noninvasive Continuous Glucose Monitoring
Noninvasive Continuous Glucose MonitoringA smart contact lens being developed jointly by Google and Novartis could measure glucose levels in tears.A second diagnostic technology Frost & Sullivan's Divyaa Ravishank expects to pick up steam is diabetes ...

9 Medical Technologies Poised to Explode in 2016: POC Testing
Point-of-Care TestingRoche Diagnostics is a leader in the POC testing space. Shown here is the company's Accu-Check Inform II system for blood glucose monitoring.Next year, Frost & Sullivan's Divyaa Ravishankar says we’ll be hearing a lot more about i...

FDA on Its Uptick in PMA Approvals
CDRH head Jeffrey Shuren recently stated that the FDA would like to be the first in the world to clear medical devices, as long as it preserves its standards for ensuring safety and efficacy. With PMA approvals hitting a 15-year high, we reached out to...

Medtronic CEO Rejects Notion that Company Only Innovates Through Acquisitions
In August, the chief executive officer of Medtronic, the world's second-largest public medtech company by revenue, sat down for a wide ranging interview with MD+DI - everything from accountable care and risk-based contracts, to globalization and vario...

Startup Partners With GE to Provide Blood Flow Visualization in Cardiac MRIs
A California startup aiming to transform the world of medical imaging has forged a partnership with GE Heathcare by which doctors reading cardiac MRIs will now be able to see and quantify blood flow.The company - Arterys - claims that its cloud-based ...

Stryker Accused of Fraud and Off-Label Promotion of Bone Putty
Stryker is on the receiving end of two new product liability lawsuits related to its bone morphogenetic protein (BMP) OP-1 products, which had been approved by FDA as a "humanitarian device exemption," absolving the manufacturer from having to prove t...

What 2016 Might Bring for Chinese Medical Device Regulation
Thinking of entering the Chinese medical device market in 2016? A life sciences regulatory expert details trends you need to know, like localization and increased inspection.Marie ThibaultThe Chinese medical device market is maturing rapidly, and with ...

Which EHR System Wins the Device Interoperability Battle?
Recent results of an EHR satisfaction survey poll nearly 400 active users of the nine main EHR vendors across nine metrics including interoperability with medical devices.Arundhati ParmarOne of the biggest stumbling blocks in patient care is that devi...

An Implantable LED to Take Your Pain Away
A new flexible, biocompatible optogenetic device could help researchers better understand the neurological basis of pain, and potentially help provide relief for patients suffering from chronic pain.A wireless LED to implant in mice (Image courtesy of...

Medtronic Has a $9 Billion 'Problem'
The roughly $50 billion merger of Medtronic and Covidien freed up $9.3 billion in cash, Medtronic said Thursday. So what's next?Chris NewmarkerNearly a year after Medtronic made the controversial decision to merge with Covidien and move its official he...

Medtronic to Outpace Industry Growth in Emerging Markets
Emerging markets growth has been somewhat slower in medtech overall but Omar Ishrak expects Medtronic to buck that trend. Arundhati ParmarMedtronic CEO Omar Ishrak has pointed to globalization as one of the three legs on which Medtronic's future growt...

PMA Approvals Hit 15-Year High
FDA's PMA approval rate was 98% in the most recent fiscal year. The agency hopes to further improve device approval timelines while simultaneously safeguarding patients. Brian Buntz and Chris NewmarkerPMA approvals are now substantially quicker than t...

Solid-State Batteries Make for Smaller Medical Devices and Fewer Procedures
Solid-state batteries, which are small, efficient, long-lasting, and capable of being recharged remotely, offer advantages for medical devices.Dr. Lonnie JohnsonWhile most people who have had an implant placed into their body are thankful for the medi...

The Amazing Water Adhesive Developed at MIT
The synthetic, sticky, biocompatible hydrogel is mostly water, and can help suspend a 55-lb weight.Qmed StaffEngineered hydrogel being pulled away from a glass surface. (Image courtesy of Felice Frankel and MIT)MIT researchers recently announced strid...

How to Pick the Right 3-D CAD Package
Medical device makers should closely evaluate system features and the vendor’s community reach when choosing a 3-D CAD package.John CioffiChoosing a 3-D CAD package today is significantly different than it was 10 years ago. If you were to take to your...

Is Medtech's Next Big Thing Years Away?
It could take years before transcatheter mitral valve replacement truly hits the market, an analyst in the space is warning.Nancy CrottiThis screen grab from an animation shows the Tendyne Bioprosthetic Mitral Valve deploying. Abbott announced in July...

Particle Measuring Systems Announces the BioCapt® Single-Use Microbial Impactor for Air Sampling
New microbial air sampler minimizes false positives and eliminates costly sterilization steps 

Why Healthcare Needs to Be Destroyed to Be Saved
A medical futurist called for seismic shifts in healthcare to make it more efficient, transparent, and customer friendly, arguing that technologists should play a leading role in driving that change.Brian BuntzSo you want a healthcare revolution? That...

Google Files Patent for Surgical Laser Technology
A recently published Google patent describes a laser ablation device with an active tracking system that allows the laser to work even when a patient is moving.Nancy CrottiAn illustration from Google's patent application for the laser ablation deviceG...

Phillips-Medisize Receives IMDA Award
Phillips-Medisize receives this year’s In-Mold Decorating Associations, Best In-Mold Decorated Part Gold award.

Public Safety Warnings from FDA Spike in 2015
FDA has had a been a busy year releasing Medical Device Safety Communications safety communications. Outlined in the warnings include problems related to duodenoscopes, reprocessed flexible bronchoscopes, and cybersecurity. Qmed DailyTo date, FDA has r...

The Medtech Industry Can't Hide from Security Flaws
The medical device industry should more thoroughly consider the security ramifications of wireless technology in next-gen medical devices, according to a prominent security researcher.Brian BuntzJay RadcliffeAre medical device designers so enamored wi...

There's Still Hope for Medical Device Startups
Much of the venture funding for medical devices has dried up. But that's not necessarily a bad thing, said members at a panel at BIOMEDevice San Jose. Brian BuntzOpportunities abound in the medical device space.That was the impression one got from list...

Top Medtech Companies of 2015: Who's Up and Who's Down?
In a game of Chutes and Ladders among medtech's top companies this year, some of the industry's biggest names rose while others fell down in the ranks.Jamie HartfordSince megamerger mania swept the medical device and diagnostic industry in 2014, there...

Top Medtech Companies of 2015: Who's Up and Who's Down? Cardinal Health
Cardinal Health: +1Dublin, OH-based Cardinal Health climbed one spot in the top 10 rankings this year, reaching No. 7. The company bought up Johnson & Johnson's Cordis division for $2 billion this past March.            See where your company stands i...

Top Medtech Companies of 2015: Who's Up and Who's Down? Fresenius
Fresenius: +2Fresenius's multiFiltratePRO system for continuous renal replacement therapy debuted in 2015.Germany-based Fresenius, a provider of dialysis equipment and services, jumped up two spots in the top 10 rankings in 2015, landing at No. 4. Thi...

Top Medtech Companies of 2015: Who's Up and Who's Down? GE
GE: –2GE Healthcare was a pioneer in miniaturizing ultrasound, as evidenced by its Vscan handheld ultrasound device.Although it's still sitting pretty high in the top 10 , GE Healthcare lost its No. 2 spot to Medtronic this year, falling one spot, to ...

Top Medtech Companies of 2015: Who's Up and Who's Down? Medtronic
Medtronic: +1FDA approved Medtronic's Evolute R TAVR system this year.Thanks to its megamerger with Covidien, which completed early this year, Medtronic rose one spot in the top 10 rankings this year, ending up at No. 2. The Ireland-based company also...

Top Medtech Companies of 2015: Who's Up and Who's Down? Novartis
Novartis: +1Novartis is codeveloping a smart contact lens with Google that could go into human trials in 2016.Swiss pharmaceutical giant Novartis, whose portfolio includes the Alcon eye care brand, climbed one spot in the top 10 rankings, landing at N...

Top Medtech Companies of 2015: Who's Up and Who's Down? Philips
Philips: –2Philips inked a managed equipment services agreement covering the Mackenzie Richmond Hill Hospital, pictured here, and the future Mackenzie Vaughan Hospital.Despite signing Canada's largest managed equipment services agreement this year, Am...

Top Medtech Companies of 2015: Who's Up and Who's Down? Siemens
Siemens: –2Siemens's Multitom Rax Robotic X-Ray System was cleared by FDA in November 2015.Despite winning FDA clearance for new CT scanners and a robotic x-ray system in 2015, Germany-based Siemens dropped two spots in the top 10 rankings, coming in ...

Top Medtech Companies of 2015: Who's Up and Who's Down? Stryker
Stryker: +1MAKO Surgical's surgical robotics platform gained some traction in 2015.Kalamazoo, MI-based Stryker moved up one spot to break into the top 10 rankings this year, landing at No. 10. The company benefitted from increased adoption of MAKO Sur...

Want to Get Funded? Don't Forget Your IP
Intellectual property may not be the most sexy topic to an entrepreneur with the next killer idea for a product, but without it, the idea will die a quick, penniless death. Arundhati ParmarEntrepreneurs, be it in the medtech world or elsewhere, are so...

And the Lines Continue to Blur Between Device and Pharma
Pharma companies are working with makers of FDA-cleared digital devices to gather information about adherence and prove that drugs work if taken regularly.Arundhati ParmarWith the onset of value-based care, unlikely and unprecedented collaborations ar...

How to Choose the Right Springs for Your Medical Device
Picking a spring with the proper action, material, and feel can be critical to the success of a medical device.Martyn TyndallShown is an example of a compression spring.It goes without saying that building a medical device requires absolute precision,...

Human Gene Editing Tech Sparks Debate
Synthetic biologists continue to advance a molecular editing system known as CRISPR that provides the opportunity to edit the DNA of living cells with unprecedented precision. While the technology's ability to safely alter human DNA has yet to be prov...

Startup’s Plan to Use AI to Resurrect the Dead Raises Eyebrows
A startup states that it can give humans the option of immortality within 30 years. While it has received international media attention, details of its plans remain scarce. Qmed StaffHumai states on its website that it is working towards "Human Resurr...

U.S. PTO Denies Request By Bos Sci to Review Nevro Patent
The United States Patent and Trademark Office has denied an inter partes review request by Boston Scientific relating to a patent held by Nevro, a medical device developer treating chronic pain.An inter partes review is requested by someone who wishes...

Does Disruptive Innovation Really Have to Be So Disruptive?
The rate that technological breakthroughs are being developed continues to increase at breakneck speed, leading to seismic shifts in how people interact with technology on a daily basis. It is thus vital to ensure that developers of new technologies c...

Medtronic Recalls Nearly 100,000 Pacemakers
The medical device company reports that a battery problem in one of its pacemakers could interfere with normal device function.Qmed StaffA recent recall involving roughly 96,800 InSync III pacemakers has been given Class 2 status by the FDA. The recal...

Modular Design Works for Google and IKEA, but Does It Work for Medical Devices?
A recent trip to Sweden, a hub of modular design, inspired this engineer to reflect on the pros and cons of modular design for medical devices.Nigel Syrotuck A number of buildings in Sweden take advantage of modular design to reuse parts.Modulär Kons...

Particle Measuring Systems Completes ISO/IEC 17025 Assessment with Zero Deficiencies
Accredited calibrations for select products can now be conducted at the corporate headquarters with the latest international standard.  

St. Jude Launches World's First Upgradeable Chronic Pain Management System in Europe
St. Jude Medical announced Monday that it is launching the world's first and only software upgradeable, nonrechargeable spinal cord stimulation system for chronic pain patients in Europe.The Proclaim Elite Spinal Cord Stimulation System is also MR-con...

The Guide to the Future of Medicine: Infographic
Learn more about user-centered design in a workshop dedicated to the topic at BIOMEDevice San Jose, December 2-3.

Top 10 Biomedical Engineering Schools by Salary
Engineering is one of the most handsomely rewarded academic disciplines and, engineering continues to be the highest-paying major at the baccalaureate level. Biomedical engineers' compensation is competitive with the pay offered by many other engineeri...

Indian Government Scrutinizing Price of Medical Devices
After allegations arose that multinational device makers were inflating maximum retail price of products, the Indian government has asked them to submit price details.Arundhati ParmarAs hospitals place pricing pressure domestically on device makers, t...

Your Medtech Summer Reading List: How to Get What We Pay For
How to Get What We Pay For: A Handbook for Healthcare RevolutionariesHealthcare futurist Joe Flower posits that we can fix healthcare in How to Get What We Pay For: A Handbook for Healthcare Revolutionaries. The key, he writes, is to get all stakehold...

Data Breaches are a Costly Threat to Healthcare
888 data breaches in the first six months of the year alone are straining the healthcare industry and putting a huge financial burden on it.Arundhati Parmar2015 has had quite a few data breaches and it's something that needs to be taken more seriously...

Invitae Grows Its Genetic Testing Menu
Marie ThibaultInvitae offers testing for hundreds of genes, covering hereditary cancers, epilepsy, arrhythmias, and more.Invitae Corporation, a genetic testing company based in San Francisco, has a lofty goal—to offer a single service with hundreds of ...

Is This a Cheaper Way to Do Medical Imaging?
MIT researchers used sophisticated mathematical equations to turn an off-the-shelf depth sensor, such as a Microsoft Kinect, into an biomedical imaging tool.Nancy CrottiThese images depicts the phase information contained in six of the 50 light freque...

Less Invasive Procedures Mean Extrusions Get Thinner, Narrower
Frank VinluanTE Connectivity can make extrusions in a wide range of shapes and sizes to meet the needs of medical device companies. For some patients who have aortic valve stenosis, or the narrowing of the heart’s aortic valve, open chest surgery is d...

Major Expansion for Creganna Medical, Minnesota
Creganna Medical opens new manufacturing facility in Plymouth, Minnesota

Medtronic Spends $110 Million on Latest Acquisition
The Aircraft Medical buy allows Medtronic to expand the endotracheal tubes portfolio of its Covidien division.Aircraft Medical's McGrath Mac (Image courtesy of Aircraft Medical)Nancy CrottiMedtronic recently announced that it has purchased Aircraft Me...

PTI Engineered Plastics “Top Workplace” in Michigan - That’s What Their Employees Say!
PTI Engineered Plastics makes the list of “Top 100 Workplaces” in Michigan

And Another One Flies the U.S. Coop
The topic of corporate tax inversions rears its head with Pfizer announcing it will acquire Allergan for more than $150 billion and move tax base to Ireland.   Arundhati ParmarAnd another one has flown the coop from the U.S. to the Emerald Isle - Irel...

Dialysis Company CEO on Ways to Improve Chronic Care
Marie ThibaultMedical treatments for patients with a chronic disease make up 86% of America's health care costs, according to the CDC. Yet despite all that spending, most experts agree that chronic care is far from perfect. Chronic diseases are the cau...

Do These Medtech Research Breakthroughs Blow Your Mind?
Do These Medtech Research Breakthroughs Blow Your Mind?Chris Newmarker November 23, 2015 Words such as “revolutionary,” “breakthrough,” and “mind-blowing” are all-too-common when it comes to describing research developments related to medtech. But whic...

FDA Warns About Deadly Device Coatings Problems
Coating adhesion problems related to guidewires and other devices apparently aren't going away, if a Monday safety communication out of FDA is any indication.Chris NewmarkerSome failing wires experience PTFE delamination. (Image courtesy of Surface So...

Here Are 5 Examples of Turning A Smartphone Into a Medical Device
A video slideshow of five technologies that are aiming to apply the power of smartphones and/or tablets to the world of healthcare, and, in some cases, regulated medical devices.Arundhati ParmarThe smartphone has been like manna from the heavens for t...

Here Are 5 Examples of Turning A Smartphone Into a Medical Device (AliveECG)
Name of Product: AliveECGDeveloper: AliveCor (product is FDA approved)What it Does: Snaps on to the back of most Apple and Android smartphones to be able to record heart rate and detect atrial fibrillation from the fingers of both hands. Companion App...

Here Are 5 Examples of Turning A Smartphone Into a Medical Device (CellScope Oto)
Name of Product: CellScope OtoDeveloper: CellScope Inc.What it Does: A case is attached to an iPhone and the otoscope, which is an ear exam device, is attached to the case. The portable Oto Home device, which is compatible with Welch Allyn otosccope t...

Here Are 5 Examples of Turning A Smartphone Into a Medical Device (Smartphone Infection Dx)
Name of Product: It is a smartphone accessory to diagnose infection diseasesDeveloper: Fu Foundation School of Engineering and Applied Science, Columbia UniversityWhat it Does: A dongle is attached to a smartphone drawing power from its audio jack to ...

Here Are 5 Examples of Turning A Smartphone Into a Medical Device (ThermoDock)
Name of Product: ThermoDockDeveloper: Medisana AGWhat it Does: It's an infrared temperature measurement device that can be attached to an iPod, iPhone or an iPad. Once attached, the app automatically launches and the person taking a temperature can br...

Pfizer and Allergan's Huge $160 Billion Inversion Deal
The U.S. Treasury has been trying to hinder such deals since Medtronic's roughly $50 billion purchase of Covidien. It apparently isn't working. Nancy CrottiPfizer apparently wants to prove that there's more than one way to avoid U.S. corporate taxes. T...

The Medtech OEM's Guide to Contracting for Services
It's important to ensure you have the correct terms in contracts for services before you sign on the dotted line.Henry Kopf and Amish PatelCompanies across the globe in all sectors are reducing fixed costs as a means to increase corporate profitabilit...

Thermally Conductive, Electrically Insulative Two Part Silicone Meets NASA Low Outgassing Specifications
MasterSil 972TC-LO is capable of transferring heat while retaining superior dielectric properties. It bonds well to a wide variety of substrates, including metals, composites, glass, ceramics as well as many types of rubber and plastics. The system has...

The Six 2015 FDA Guidance Documents You Need to Know
Gordon MacFarlane, PhD, RAC, Sandra D. White, MS, RAC, and Cynthia Nolte, PhD, RACThis year has been highly productive for FDA. Among the agency’s many achievements are several guidance documents that have substantial, positive implications on portfol...

5 Ways Micromolding Improves Drug-Delivery Devices
OEMs can turn to micromolding to help cut costs and enhance performance of drug-delivery devices. Lindsay Mann Micromolding can produce parts that are much smaller and more detailed than those possible to make using traditional molding processes.The a...

COC Resins – the workhorse behind Bemis Healthcare Packaging’s Proprietary CXB™ Sealant
Bemis Healthcare Packaging announces to the industry know that the commercial version of this sealant utilizes TOPAS® cyclic olefin copolymer (COC) resin.

Future Device Technologies Decoded
MD+DI associate editor Marie Thibault discussed the future of medtech with TechnologyAdvice Expert Interview podcastJosh BlandMarie Thibault, associate editor at Medical Device and Diagnostic Industry, was a recent guest on the TechnologyAdvice Expert...

How Realistic is AMA's Call For Ban on Direct-to-Consumer Ads for Drugs, Devices?
The American Medical Association is asking for a ban on direct-to-consumer advertising of prescription drugs and devices, but how realistic is it in the era of consumerization of healthcare. Arundhati ParmarEarlier this week the American Medical Assoc...

Medtech Hacking: The Newest Way to Scare TV Watchers
A recent episode of "CSI: Cyber" aired in which all of the networked medical devices in a hospital were hacked. It may be sensationalized, but the argument that many networked medical devices are relatively insecure is correct. Brian BuntzIt seems the...

Meet the IBM Watson Health Competitor Turning Elusive Data into Individualized Care
Marie ThibaultApixio's HCC Profiler, based on the Iris platform, is used to calculate accurate risks for patients.You've heard of IBM Watson Health, but how about Apixio? The San Mateo, CA-based company, founded six years ago, is dedicated solely to h...

Pfizer-Allergan Reportedly Nearing $150 Billion Merger
Medtronic became the biggest company in Ireland through its $50-billion acquisition of Covidien. Pfizer's pending buy of Allergan will reportedly cost it three times as much. Pfizer, however, is also dropping hints that it plans on breaking up its busi...

Strategic Outsourcing for Medtech OEMs
A new MD+DI ebook sponsored by Cirtec explains how strategic outsourcing partnerships can help you cut costs and fuel innovation.The medtech industry today is changing rapidly, with products growing increasingly complex and competition getting stiffer...

Teleflex Medical OEM’s Latest Innovation: Force Fiber® OrthoTape™ Braid

The 2 Latest Medical Devices with Mobile Health Credibility
St. Jude Medical now has an FDA-approved spinal cord stimulation system that can be programmed with an iPad mini. And Philips has started selling its app-based ultrasound Lumify system--on a subscription basis. Chris NewmarkerSt. Jude Medical's new Pr...

The Three Devices You Thought Were the Hottest of 2015
We asked you to vote for the most-promising medical technologies that launched in Europe or the United States this year. Here are the three that came in on top. Qmed Staff1. Micra--79.39% HotThe Medtronic Micra leadless pacemaker was developed in hous...

7 Things to See at BIOMEDevice San Jose
 From discovering the future of medtech--to perhaps meeting your next business partner--there will be plenty to check out at BIOMEDevice San Jose. Qmed StaffBIOMEDevice San Jose offers a great chance to network with your medtech industry peers. Here a...

Can Device Therapy Manage Diabetes Better?
Arundhati ParmarType 2 diabetes is an expensive, chronic condition that has been managed for decades using drugs in combination with regular exercise and close monitoring of patients' diets.But some startups are taking a device approach to tackling th...

Hackers Could Hold Medical Devices Hostage
Next year, hackers will could begin threatening the lives of people with implantable devices according to a prediction by a tech market research firm. Brian BuntzRansomware could be headed to the world of medical devices and wearables, according to Fo...

How to Design a 'Tricorder' That Could 'Hear' Cancer
Stanford University researchers think they are four to five years away from a handheld, cancer-detecting device. Slideshow: 10 Star Trek-Inspired Medical Devices You Need to Know AboutNancy CrottiEver since Dr. Leonard "Bones" McCoy first waved his "t...

Pfizer and Allergan Reportedly Close to a Deal as Treasury Reviews Inversions
Marie ThibaultVarious media outlets are reporting that even as the U.S. Treasury may be preparing to adopt a stricter stance toward corporate tax inversions, Pfizer is continuing to pursue a potential acquisition of Allergan. If the massive merger gets...

Startup Boards Need to Consider 3 CEO Archetypes For Success
Startup boards need to realize that the same founder/CEO may not be the perfect leader as the company matures and evolves.Morten NielsenAlthough some medical device, diagnostics, and other life sciences startups evolve from inception to full-scale com...

Which of These Med Devices Are Hot and Which Are Hyped?
Which of These Med Devices Are Hot and Which Are Hyped?From leadless pacemakers that can fit inside the heart to ultrasound devices that run off smart tablets, new medical devices continue to hit the market.Listen to a medical device company’s marketin...

Boston Scientific Recalls 955 Guidewires after Patient Death
Boston Scientific is overseeing a Class I recall of the RotaWire Elite guidewire after being granted a PMA Supplement from FDA to change the contract manufacturer and the branding of the device. The device was sold to 30 hospitals as part of a "limite...

FDA Manages High-Risk Devices Nervously
A number of medical devices have come under fire this year, but FDA doesn't have "imminent hazard" authority to take a device off the market. Even if FDA did have such authority, would it put it to use?Jim DickinsonUnlike its much-earlier (1938) manda...

How a Sunscreen Ingredient Could Thwart Superbugs
Zinc oxide nanopyramids could protect pacemakers, replacement joints and other implantables from MRSA and other pathogens, according to University of Michigan researchers.Chris NewmarkerThis illustration shows a pacemaker lead coated with nanoscale zi...

Learn From Theranos’s Mistakes: An Analysis of the Form 483s (Part I)
Startups should heed the Theranos warning: When you raise millions of dollars to develop a product, remember the processes that help get that product to market, including proper implementation of a robust quality management system.David AmorTheranos C...

Medtronic's Ishrak Is Getting Hometown Love
Medtronic CEO Omar is the executive of the year, according to a Twin Cities-based publication. Ishrak earlier this year also handily topped a Qmed poll asking readers to pick the best medtech chief executive.Medtronic CEO Omar IshrakQmed StaffOmar Ish...

Startup Turning Smartphone Case to Glucometer Launches Crowdfunding Campaign
Arundhati ParmarA California startup that has reimagined the smartphone case as a glucose meter has launched a crowdfunding campaign to raise $50,000.AkibaH has created the GluCase, which it bills as the world's first  smartphone case glucometer that ...

What Consumers Want to See in Medical Products
Marie ThibaultA new Harris Poll survey finds that over 75% of surveyed U.S. adults would buy home-use medical products, and there are a few other product characteristics that would encourage purchase, including the ability to lower healthcare costs and...

5 More Ways to Kill Innovation in Your Company
5 More Ways to Kill Innovation in Your CompanyChris Newmarker and Brian BuntzNovember 17, 2015Want to figure out how to bring more innovation to your company? A good start is to know what not to do.That’s a favorite mental exercise for Ted Harro, found...

FDA Commissioner Nominee Grilled Over Adverse Events
Robert Califf, MD, faced some tough questions during a Senate committee confirmation hearing about how he would handle medical device and drug regulation as FDA chief. Brian BuntzWhile Califf stated he would work to streamline medical product approval...

FDA Makes Case for LDT Oversight
Marie ThibaultFDA has made no secret of its interest in regulating laboratory developed tests (LDTs) and this week, the agency bolstered its case by releasing a report on 20 cases where LDTs harmed or had the potential to harm patients.In "The Public H...

FDA Orders Recall for Endoscope Reprocessors
FDA has instructed Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs), and recommended that health care providers find alternative processing methods "as soon as possible."Nancy CrottiFDA has found that the company Custom U...

Medtronic Gives App Capability to Remotely Monitor Pacemaker Patients
Medtronic gets FDA approval for an app enabled portable device reader that can transmit pacemaker data to physiciansMedtronic announced Tuesday that it has created a companion app to its pacemaker system whereby patients can use their smartphone or ta...

Orchid Acquires Cam Bioceramics Coating Facility in Suzhou, China - Expands Coating Capability
Holt, MI - Orchid Orthopedic Solutions (Orchid), a worldwide leader in design and manufacturing for the orthopedic and medical device industry, is pleased to announce it has signed an agreement to acquire the Cam Bioceramics coating facility and ...

Adoption of Drug-Coated Balloons Set to Increase
Drug-coated balloons will be used more often in treating periperal artery disease in the U.S. at the expense of standard angioplasty and peripheral stents.Arundhati Parmar The IN.PACT Admiral drug-coated balloon is inflated and inserted into the block...

Google's $25 Million Bet to Cure Heart Disease
With the American Heart Association matching the money, the goal is to spend $50 million over five years on a single, to-be-determined research effort.Slideshow: The Year High Tech Got Serious about MedtechChris NewmarkerCall it another example of Goo...

How to Minimize Vendor and Supplier Disputes in Medtech
It is paramount for medical device companies to ensure standard purchase and supply documents address key requirements, legal terms, and specifications.Henry Kopf and Amish PatelIn the medical device industry, most companies are both buyers and seller...

How to Power Bioelectronics with Light
Scientists out of China propose the use of a light-driven device that can power bioelectronic implants through the use of near-infrared rays and flashing light pulses.An illustration from the Chinese researchers' paperKristopher SturgisNanotechnologie...

Is the U.S. or Europe the True King of Medtech?
While the United States has traditionally been a global leader in the medical device field, Europe appears to be gaining ground--at least in terms of the major medical device companies based there. Brian BuntzImage from EucomedConventional wisdom has ...

Keeping a Remote Eye on Reprocessing Techniques
Marie ThibaultDespite this year’s various recommendations and FDA guidance on effective reprocessing, concern about potentially contaminated flexible endoscopes, in particular duodenoscopes, remains. Training, staff turnover, and detailed protocols can...

3 Medical Device Trends to Know
The impact of the Internet of Things and digital health disruption--those are but some of the things Qmed senior editor Chris Newmarker discussed in a recent online interview.Qmed StaffQmed senior editor Chris Newmarker spoke of everything from reporti...

Connected Device Security: Why It's Getting More Serious
FDA is due for more scrutiny over whether it is sufficiently regulating hospitals' networked medical device.Chris NewmarkerThe Inspector General Office at the U.S. Department of Health and Human Services has a new item on its to-do list: determine whet...

In-Person Ways to Avoid Form 483 Observations and Warning Letters
An FDA inspection can be nerve-wracking. Learn what two experts say you can do in person during an inspection to avoid receiving Form 483 observations or a warning letter.Marie ThibaultFor many medical device companies, it's a scary idea that an FDA in...

Is There a Disconnect over Medical Device Indications?
If it looks like a duck, swims like a duck, and quacks like a duck, then it's probably a duck. While that "duck test" may be true for fowl, determining how medical devices are used in patients is a trickier subject.Qmed StaffWhile medical devices are g...

Move Over Wearables: Here Come Holograms and Cardiac Photosharing Apps
USC has unveiled a photo-sharing app that tracks heart metrics and a virtual clinic that make use of hologram-based doctors.Qmed StaffWhile perhaps no other digital health technology has gotten as much attention as wearables, there are countless possib...

Will Digital Medicine Replace the Clinician?
Ben TorresThe fear of being replaced pierces right through the heart of technology-resistant clinicians, generating notions that something like the Skynet will somehow terminate healthcare providers and replace them with robots that provide patient ca...

2015: The Year High Tech Got Serious about Medtech
2015: The Year High Tech Got Serious about MedtechFrom Google working with J&J on surgical robots to Samsung partnering with Medtronic on diabetes management, this was the year that iconic high tech companies went full bore when it came to pursuing opp...

Alarm Problems Can Contribute to Deaths and Injuries
Creating an effective medical alarm may sound straightforward on the surface, but it is anything but. Up to 72-99% of alarms that go off in hospital settings are false, according to a 2013 article in the American Association of Critical-Care Nurses (A...

Contaminated Endoscopes the Top Health Tech Hazard
Contaminated endoscopes and in particular, duodenoscopes, are the ECRI Institute's top health tech hazard for 2016, following a year of news about infectious bacterial outbreaks and ineffective reprocessing practices.Marie ThibaultThe Emergency Care Re...

Gamma Camera Defects Can Be Deadly
ECRI Institute and FDA have received multiple reports of mechanical failures linked to gamma cameras, which can threaten patients and hospital staff members. In the past two years, there have been more than 40 recalls linked to the devices, which are ...

How 23andMe Made Its Comeback
Nearly two years after the genetic testing company drew FDA's wrath, it is back selling health-related tests.Chris NewmarkerThe contents of 23andMe's saliva collection kit. (Image courtesy of 23andMe)Blood testing Theranos may be the latest Silicon Va...

Intensive Care Ventilator Problems
As the ECRI report explains, inappropriate patient ventilation can cause lung injury in intensive care patients, possibly proving fatal in some cases. While ventilators include modes and features designed to address this problem, ventilator-induced lu...

Is Boston Sci Facing a Major Setback?
Executives at the medical device giant have had high hopes for the Watchman heart device. But proposed CMS guidelines could limit Medicare coverage.Nancy CrottiThe Watchman's features include a self-expanding nitinol frame in five sizes, PET mesh fabr...

Qmed Reader Survey
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Startup vs. TAVR Goliaths: A Tale of Polymer Against Metal
Arundhati ParmarThe Direct Flow Medical Transcatheter Aortic ValveTAVR System with polymer rings Many expect transcatheter aortic valve replacement will become the standard of care in the future for patients who suffer from aortic stenosis. Up to 1.5 ...

Supersealer MHS

USB Port Glitches in Medical Devices Trigger Recalls
Many medical devices have USB ports. Plugging unauthorized devices into those ports can cause an array of problems, triggering, for instance, some physiologic monitors to reboot according to the ECRI Institute report. Last year, ArsTechnica reported t...

Cloud Considerations for Medical Device Makers
Thinking of connecting your medical device to the cloud? Here are a few things you should know.Dana GoodIt's an exciting time in the medical device industry, with new “cloud-connected” systems emerging every day that offer significant new value to pat...

Expedited Access for the Wearable Artificial Kidney
Nancy CrottiThe Wearable Artificial Kidney allows continuous blood purification for dialysis patients. FDA has granted its new Expedited Access Pathway status to the Wearable Artificial Kidney (WAK) following a clinical trial at University of Washingt...

GE Finds Alternative to Weapons-Grade Uranium for Medical Imaging
Medical imaging institutions in the United States may land a domestic source of the isotope that makes many scans possible, made with lower-strength uranium than the diminishing overseas supply.Nancy CrottiGE Health Care and Wisconsin-based Shine have ...

Improper Cleaning of Flexible Endoscopes Can Spread Superbug Infections
Few other medical device problems received as much attention in the press in 2015 as a duodenoscope's potential to spread pathogens. The devices were associated with outbreaks in hospitals in Seattle, Los Angeles, and outside Chicago, ultimately promp...

Safeway May Be Cutting Ties with Theranos
Theranos continues to get hammered by negative press from the Wall Street Journal. This time, the paper says Safeway executives are severing ties. Theranos claims the report is defamatory. Qmed StaffA Theranos Timeline2003 Elizabeth Holmes founds Thera...

Top 5 Medical Device Dangers to Avoid in 2016
While faulty alarms continue to be a perennial risk, several of the other top medical device technology risks cited in ECRI's annual roundup of health technology hazards have gotten relatively little recognition. Qmed Staff 1. Improper Cleaning of Flex...

Tough Medicare Reimbursement Proposal for Watchman
Marie ThibaultThe Watchman left atrial appendage closure (LAAC) device had a bumpy road to approval and it looks like its journey toward Medicare reimbursement may not be any easier. In April of this year, Boston Scientific submitted a formal request t...

Apple Hints at Its Medical Device Plans
Before the Apple Watch debuted, the product was rumored to have medical device functionality. Now, Apple chief Tim Cook is saying that future iterations of the Apple Watch won't have medical functionality either, but stated that it may produce "adjace...

BIOMEDevice 2015
Sil-Pro Medical Manufacturing Solutions announces its participation in the 2015 BIOMEDevice

Brits Drop Fraud Case against Olympus
The British Serious Fraud Office has dropped a two-year case against Olympus Corp. and a British medical equipment subsidiary, which it had accused of making misleading statements to auditors.Nancy CrottiThe case sprang from a high-profile accounting s...

Corporate Venture Capital Investment in Life Sciences is Increasing
Arundhati ParmarA new report shows that participation of corporate venture capitalists in life sciences investing has been increasing.The MoneyTree report from the National Venture Capital Association and PricewaterhouseCoopers with data from Thomson ...

Humanizing Implantables: The 'Invisible' User Experience
Today's implanted medical devices hold the potential to support wellbeing and proactively address preventable diseases in a more meaningful way than wearables ever could. But there are some glaring problems--including the "creepy factor" of implanting...

Microscan Offers World’s Smallest, Most Flexible Barcode Readers for OEM Installations
Microscan's new MicroHAWK platform includes the world's smallest barcode readers with the most configurable hardware/software options to meet specific application requirements within machines and OEM equipment.

Philips Adds a New Hospital System to Partnership Strategy
Marie ThibaultThe Mackenzie Richmond Hill Hospital, pictured here, and the future Mackenzie Vaughan Hospital, will be included in the new partnership.Royal Philips was one of the pioneers of the collaboration model between the medtech industry and indi...

Test-5 Ways to Kill Innovation in Your Company
InnovationBuzzkill_0.jpeg Type Image Gating level anonymous user DataTable subpages Media Image Source ID 19914 ...

5 Ways to Kill Innovation in Your Company
Chris NewmarkerNovember 9, 2015Wondering why people in your company often come up short on new ideas?Odds are, you have a problem with your corporate culture, says Ted Harro, founder and president of Noonday Ventures, a strategy facilitation and leader...

How Do Micra Results Compare to Nanostim Data?
Marie ThibaultMedtronic announced Monday that its Micra Transcatheter Pacing System (TPS) met safety and effectiveness endpoints in its Global Clinical Trial by "wide margins." Almost all patients—99.2%—were successfully implanted with Micra. Fewer pat...

How Medical Device Makers Can Encourage Patient Engagement
A Deloitte survey finds that patients are becoming more involved in their healthcare, but the different consumer demographics mean device companies must devise unique strategies to encourage more patient engagement. Here's how device makers can get in ...

Pfizer-Allergan Deal Would Dwarf Medtronic-Covidien Merger
Medtronic became Ireland's biggest company by spending $50 billion for Irish-domiciled Covidien. The Pfizer-Allergan deal could be three times bigger. Qmed StaffMedtronic received unwelcome attention last year from the Obama administration, which tried...

RoHS, REACH and the Rest: EU Substances Regulation Applicable to Medical Devices and IVDs
An overview of everything you need to know about EU legislation restricting hazardous substances from use in medical and IVD devices placed on the market in EU member states.Dr. Alex MartinMedical and in vitro diagnostic (IVD) devices are among the mo...

Should Intuitive Surgical Worry About Whether Robotic Surgery is Cost Effective?
Intuitive Surgical has sold more robots in the U.S. amid forecasts of growth of the broader robotic surgery market. Does the company need to build a case around cost effectiveness any more?Arundhati ParmarIntuitive Surgical's da Vinci Xi surgical robo...

Whistleblower Sues Zimmer-Biomet for $10 Million over Kickbacks
Former Biomet employee Michael Swiss alleges that Biomet engaged in a kickback campaign and that the company orchestrated  a 13-month retaliation campaign against him when he blew the whistle on the company.Qmed StaffA former Biomet sales rep, Michael ...

Another Example of Digital Therapies Getting FDA Clearance
Digital health startup Reflexion Health has won FDA clearance for it Vera virtual rehabilitation system that allows joint replacement therapy to do their exercises at home. Arundhati ParmarSan Diego-based Reflexion Health announced this week that its ...

FDA Eases Up a Bit on Enforcement Gas Pedal
Medical device warning letters and domestic inspections continue to show a slow decline...

Holograms and Cardiac Apps: The Next Frontier of Digital Health
Several recent projects at USC unveiled plans for virtual clinics,  photo-sharing health apps, and hologram doctors as developers prepare for the future of healthcare. Qmed StaffThe University of Southern California's (USC) Center for Body Computing (C...

How the Robots Apocalypse Could Affect Medtech
"We are facing a paradigm shift which will change the way we live and work," proclaims a recent report on robotics from Bank of America, which touches on the technology's potential to disrupt healthcare and manufacturing. Qmed StaffSome of the worst-c...

The Best Medtech Products and Services of 2015
Qmed StaffOne product that has especially caught our eye at Qmed is Langford IC Systems’ “LIC” machine. UCLA’s Ronald Reagan Medical Center has installed the LIC machine to clean endoscopes in the aftermath of a deadly superbug outbreak, according to a...

Unmet Needs: Inspiration for Medtech Inventors
Physician inventors discuss what they see as the greatest unmet needs in pediatrics, cardiology, gastroenterology, and more. Marie ThibaultIn a popular, packed session at this week's MD&M Minneapolis conference, three physician inventors talked about t...

Dexcom Hitches Its R&D Wagon to Google
Arundhati ParmarIn August, continuous glucose monitoring device maker Dexcom announced that it was collaborating with Google to develop and commercialize next-gen continuous glucose monitoring products that are smaller, cheaper, lighter and disposable...

Disposable Liquid Flow Sensors for Biomedical Applications

Feds Raid Fired Starkey Execs' Homes
The FBI and IRS raided the homes of two former Starkey Laboratories Inc. executives yesterday.Nancy CrottiJerry Ruzicka had been a celebrated figure for driving Starkey's success. Here is a picture of him in 2010 winning the Ernst & Young Entrepreneur...

How Lasers Are Creating Cutting-Edge IVD
Laser cutters with extremely small tolerances are playing an important role when it comes to creating microfluidics for lab-on-a-chip devices. Chris NewmarkerFabrico Medical (Rochester, NY) is bringing laser cutting to bear when it comes to creating ti...

New Sensor Provides Sense of Touch for Bionic Hands
Kristopher SturgisSensors on the fingertips of a bionic hand enabled it to have a sense of touch. The university announced that the new pressure sensor was designed in the form of a flat, flexible material that could be molded into artificial skin for...

Providers and Payers Eager to Adopt New Health Tech Quickly
Marie ThibaultText, Chat, Call . . . Advertising on the side of a bus for North Memorial's secure messaging platform for patients.While some medical device manufacturers may sometimes feel customers don't adopt their products quickly enough, healthcare...

Risk Management for Medical Devices: An Introduction to the Process [Infographic]
Risk Management is a vital component to developing and designing medical devices. Before your product goes to market, you have to know that it is safe and that you've analyzed and mitigated every risk possible.Jon SpeerThe most important standard to k...

Small Budget? Tips for Generating Reimbursement Data
Gathering enough of the right kind of data needed to secure reimbursement coverage is a big challenge that looms larger for medical device makers with a limited budget. Here are creative tips for tackling the reimbursement challenge.Marie ThibaultGetti...

2 Significant Trends Transforming Medtech
It comes down to digital health and the power of the consumer, Stacy Enxing Seng, former president of ev3, said Wednesday at Minnesota Medtech Week. Chris NewmarkerDoes this ever so snuggly sock represent the future of medtech? (Image courtesy of Owle...

A New TAVR Legal Battle Ensues
Boston Scientific has sued Edwards Lifesciences in Germany alleging that the company is infringing on a patent related to its Lotus transcatheter heart valve. Arundhati ParmarAll was quiet on the TAVR front after Medtronic and Edwards Lifesciences end...

Congressman Introduces Bill to Take Essure off the Market
Marie ThibaultThe controversy around the Essure permanent contraceptive device has now reached the halls of Congress. The Essure system, owned by Bayer following its 2013 acquisition of Conceptus, has been under scrutiny this year as a result of numero...

How the ISO 9001:2015 Revision Affects Medical Device Companies
The 2015 revision of the ISO 9001 quality standard contains fundamental changes to the structure and contents of the standard and offers a preview of some revisions to ISO 13485 expected in the coming year.Walt Murray(click to enlarge)ISO recently pub...

Improving FDA Reviews of Combination Products
The FDA and Intercenter Consultations

Medtronic Cuts 175 Jobs in Ireland
Medtronic moved to from Minnesota to Ireland to save money on its taxes. Now it says it's cutting up to 175 jobs (previous reports said 150) in Dublin to remain competitive.Nancy CrottiThe Irish Times reports that Medtronic plans to close a call center...

Phillips-Medisize Completes 33,000 sq. ft. Medical Facility Expansion
Phillips-Medisize Corporation announces the completion of the 33,000 sq. ft. expansion to their New Richmond, Wisconsin medical facility.

Power Morcellation Critics Win Restraining Order against Hospital
Hooman Noorchashm and his wife Amy Reed, physicians who launched a national campaign to stop power morcellation, were recently subjected to enhanced security procedures before Reed was admitted to the operating room for an emergency cancer surgery at ...

The 2015 Minnesota Medtech Week Innovation Prize Winner
An affordable professional-grade 3-D printer wowed the Innovation Prize tour group on Wednesday at Minnesota Medtech Week.Chris NewmarkerFrom left to right, the Form 2 3-D printer, Jory Block of Formlabs sales, JP Shipley of Formlabs marketing, Teresa...

Ventricular Assist Device Market to Grow to $1.97B By 2022
Arundhati ParmarThe global ventricular assist device market is set to grow to $1.98 billion by 2022, according to a new report.Grand View Research published a report that said that the market was worth $762.9 million in 2014. The growth is being drive...

6 Important Quotes from Medtech Leaders
Recent earnings calls for the largest medical device companies provide hints when it comes to the future of the industry.Chris NewmarkerMajor medtech companies have been wrapping up another series of quarterly earnings releases. In the process, calls ...

Avoiding Fee-For-Service Isn’t so Simple
Even though they may be accustomed to shaking up how we think of the delivery of healthcare, there’s a reason why many digital health startups still use the traditional “fee-for-service” model.Marie ThibaultThe maturation of the digital health trend ha...

Laser Microfabrication Takes on Diagnostic Consumables: Part 2
This article explains how lasers compare to traditional methods for fabricating diagnostic consumables.Glenn OguraIn Part 1 of this article, you learned about the benefits of miniaturization for diagnostic consumables, and that many of them are now be...

Lessons Learned from Theranos' Misfortunes
Theranos has been charged with being too secretive for its own good. The firm's founder Elizabeth Holmes is now vowing to be more forthcoming with data. Much of the recent controversy swirling around the company is related to avoidable regulatory misst...

PwC Dragged into $17M Burrill Fraud Suit
Noted biotech investor G. Steven Burrill had been accused of embezzling $17 million. Now, a venture firm launched by Burrill is charging PwC with being complicit in the scheme.Qmed StaffG. Steven BurrillA venture firm created by Burrill & Co. is suing...

Top Doc: Wearables Solve a Problem Called December
Top physicians are showing deep skepticism for wearables and the impact they can have on healthcare.Arundhati ParmarThe skepticism toward wearables is coming fast and furious.Dr. Robert Pearl, executive director and CEO of The Permanente Medical Group...

2015 Readers' Choice Medtech Company of the Year
Big Data is fast becoming the lifeblood of the modern healthcare system, so it makes sense that Medidata, the world’s top provider of software and analytics for medical clinical trials, came out on top of our reader’s choice poll for Medtech Company o...

And the 2015 Company of the Year Is ...
Arundhati ParmarEveryone remembers that seminal moment in the history of the Jeopardy game show when the Watson supercomputer beat humans.That was 2011, but the moment had wider ramifications beyond television history. The win crystallized the possibi...

How Long Does It Take to Bring Innovative Devices to Market?
A look at just how long it takes innovative devices to get to market via various regulatory pathways.Jamie HartfordAnyone working in medtech knows it can be a herculean task to bring an innovative medical device to market. But at last month's AdvaMed ...

MC10 Getting Ready to Shake Up Wearables Market
Arundhati Parmar An ultra-thin, flexible technology from MC10 Flexible electronics startup MC10 has made a pivot from sports medicine to the broader healthcare market and early 2016 is when the company will release its first product.A fair amount of c...

One Component Dual Cure Epoxy Meets USP Class VI and ISO 10993-5 Specifications
Master Bond UV15DC80Med is a special dual cure epoxy based system that offers a primary cure using UV light along with a secondary heat curing mechanism. This extraordinary compound also meets USP Class VI specifications and passes ISO 10993-5 testing....

Zimmer Biomet Achieving Synergies Ahead of Schedule
Marie ThibaultThe early report from Zimmer Biomet Holdings is a positive one. Management of the new combined company is seeing savings from synergies earlier than anticipated and good sales progress due to integration.According to a Seeking Alpha trans...

Achieving Cost Effectiveness in Point-of-Care Diagnostic Devices with Frangible Seals
The Point-of-Care (POC) in vitro diagnostic (IVD) market is continuing to grow, with speculation that IVD could become the leading niche in the medical device industry by 2020 with more than $65 billion in sales. POC testing is supported by continuo...

6 Medtech Predictions to Watch Out for in 2016
From home healthcare taking some baby steps to retailers driving telemedicine, there is change on the way next year, say experts at Frost & Sullivan and the design firm Nottingham Spirk.Brian BuntzGet ready for a Voltron approach to healthcare (see po...

A $250 Million Legal Settlement over ICDs
The U.S. Justice Department claimed that hundreds of hospitals across the country implanted implantable cardioverter defibrillators into people--and billed Medicare--when they should have been waiting. Could the crackdown curtail use of ICDs?Chris Newm...

FDA Guidance Answers (Some) Cybersecurity Medical Device PMA Concerns
New FDA guidance calls on the medical device community to be more proactive when it comes to developing a solid set of cybersecurity controls

Healing Broken Bones with Biodegradable Implants
Recent findings suggest a new synthetic biodegradable material could help heal bones in patients with orthopedic injuries.Kevin Baker (Image courtesy of Beaumont Hospital)Kristopher SturgisResearchers at Beaumont Hospital (Royal Oak, MI) and Johns Hop...

Obamacare is Coming into Sharper Focus
Lofty ideals like empowering patients, accountable care, and the need to disrupt healthcare as we know it are starting to sound a lot more down to earth.Jamie HartfordWhen the U.S. Supreme Court upheld the constitutionality of the Patient Protection a...

So Far, No Sign of MVAD Needing a Redesign
Marie ThibaultThe good news on HeartWare’s next-generation left ventricular assist device (VAD), the MVAD, is that company executives haven’t seen any signs that the device needs a redesign. But it seems patients, investors, and onlookers will have to ...

Study At Mayo Wields Digital Health To Fight COPD
Arundhati ParmarDigital health is gaining steam. Evidence abounds.Earlier this year, the Centers for Medicare and Medicaid Services acknowledged the power of digital health as a preventive measure that can help pre-diabetic patients from getting the f...

Theranos' FDA Headaches Could Cost Them Dearly
Theranos' regulatory troubles could cost them over $1 million, according to one regulatory expert. Here's a timeline of how they got there.Qmed StaffAn image of Theranos CEO Holmes pulled from the company's website. Blood testing firm Theranos will li...

This Is Heavy: What Does the Future of Healthcare Hold?
A visionary and vanguard of the Internet and now healthcare tells MD+DI why he thinks revenues for the healthcare industry will decline and what device makers can do to succeed.Marie Thibault"Back to the Future Day" has come and gone, but questions abo...

A Peek at the Next 510(k) Modifications Guidance
Marie ThibaultIn the latest update on a years-long process, FDA has offered more commentary on what its new 510(k) device modifications draft guidance is likely to include. Speaking this week at the Regulatory Affairs Professionals Society (RAPS) 2015 ...

Baxter Cuts 1400 Workers, Hires Ex-Covidien CEO
After a rough third quarter, Baxter has announced layoffs, and its plans to name José Almeida as its new chairman and chief executive officer, effective January 1, 2016.Nancy CrottiBaxter saw its profits nosedive in the third quarter of the year, whic...

Bos Sci Co-Founder: Medtechs that can Integrate Systems Will Win Future
Arundhati ParmarBoston Scientific's co-founder, John Abele, is a big believer of systems and the power they have in being able to drive value in healthcare.Abele, who will be a speaker at a conference in Minneapolis jointly hosted by MD&M Minneapolis ...

New Low Pressure Stopcocks with Rotating Male Luer Lock from Qosina
Qosina is pleased to announce the addition of three new low pressure stopcocks (#99770 - #99772), in inventory and ready for immediate delivery.

Orders Coming in for Varian Medical’s VitalBeam
Marie ThibaultThe VitalBeam system is a lower-priced product offering that may help increase use of radiotherapy in emerging markets.Varian Medical Systems, known as the leading global player in the linear accelerator radiation therapy market, is aimin...

4 Deaths Linked to Cardiac Device Infections
Eight people treated with a medical device used in open-heart surgery in York, PA ended up getting infections.Qmed StaffAs many as 1300 patients at WellSpan York Hospital may have been potentially exposed to a bacterial strain known as nontuberculous m...

AssurX Announces Release of Best Practices for Medical Device Complaints Handling Webinar
AssurX, Inc. announces the release of its Best Practices for Medical Device Complaints Handling webinar

Bos Sci Believes Synergy Warrants Pricing Premium
Marie ThibaultThe Synergy Bioabsorbable Polymer Drug-Eluting Stent System received FDA approval in early October.Boston Scientific executives think the company's Synergy Bioabsorbable Polymer Drug-Eluting Stent (DES) System is worth a higher price tag ...

Crafting a Reimbursement Strategy
An executive explains how a small medical device company created and executes a successful reimbursement strategy. Marie ThibaultReimbursement is a challenge that most medical device manufacturers must contend with, but for many, it remains one of the ...

Here Are Exhibitors to Check Out at Minnesota Medtech Week
Here Are Exhibitors to Check Out at Minnesota Medtech WeekQmed Staff October 28, 2015 Thousands of medical device industry experts are expected at the Minnesota Medtech Week show in Minneapolis on November 4–5, with the Expo featuring over 1000 medtech...

How Nanotech Could Improve Medtech
Considerable progress has been made in miniaturizing medical devices, says James Marti, PhD, associate program director and senior scientist at the University of Minnesota Nano Center.James MartiNancy CrottiWhere is nanotechnology going to pop up next...

How to Avoid Exponentially Escalating Costs with Design Controls
Medical device companies that identify quality problems early on can prevent product development costs from spiraling out of control, while also laying the groundwork for design verification and design validation.Jon SpeerEntering into the design veri...

Medical Device Alarms: A Delicate Balancing Act
Too many medical device alarms are akin to crying wolf; too few could neglect to alert clinicians of an emergency.Debbie McConnellWhen designing a system intended to monitor a patient’s wellbeing, deliver treatment, or both, knowing when and how to dr...

Software Solutions to Improve Medtech Manufacturing
Jamie HartfordFacing growing competition and pressure from customers to cut costs, medical device OEMs are increasingly turning to software systems for help—and for good reason.  Enterprise software, cloud computing, and the Internet of Things (IoT) a...

What You Absolutely Need in a Medtech Contract Manufacturer
Here's a hint: it involves less hand-holding, says Olympus' Nikhil Murdeshwar.Nikhil MurdeshwarChris NewmarkerAs a principal research engineer at Olympus, Nikhil Murdeshwar's job involves helping to scout out new business opportunities for the Japanes...

Designing a $93M Medical Technology: A Behind the Scenes Look
The design firm Nottingham Spirk provides the inside scoop on how a sleek advanced cardiac mapping technology was developed starting from a crude prototype.Qmed StaffThe ECVUE vest can conform to a range of patient body types. In 2006, the startup Car...

Edwards Lifesciences Bullish on TMVR But Scant on Details
Edwards Lifesciences is betting on a big opportunity in transcatheter mitral valve replacement, but offers up very few details on the status of its efforts in that area. Arundhati ParmarEdwards Lifesciences continued to wow analysts with its transcath...

FDA Warnings Shed Light on Theranos' Problems
FDA inspection documents describe the young blood testing company's nanotainer as an "uncleared medical device."Elizabeth Holmes, CEO of Theranos, has become a celebrity entrepreneur over the past year.Chris Newmarker and Brian BuntzTheranos' woes con...

Feds Open Investigation into Valeant's Contact Lens and Drug Practices
The Federal Trade Commission is investigating whether Valeant Pharmaceuticals International has gained a monopoly on the market for one of the main components of rigid contact lenses. Last month, House Democrats filed for a subpoena for documents that ...

MD&M 2015
Sil-Pro Medical Manufacturing Solutions announce its participation in the 2015 MD&M Minneapolis Show.

Optinova Introduces our New Line of Etched PTFE Liners
Optinova introduces its PTFE liner

Tweaking 3-D Printers to Produce Live Heart Models
A group of researchers from Carnegie Mellon University (CMU) have developed a technique that can transform a range of consumer-level 3-D printers into bioprinters -- producing 3-D models from soft materials that assemble into common tissue.Kristopher ...

Bringing a ConsumerMed Device Home
A design expert offers advice on designing "ConsumerMed" products for home use, including important considerations for training, patient input, ease-of-use, and connectivity.  Marie ThibaultIt's no wonder that consumer medical devices are a rapidly exp...

Heard About Theranos? Here Are 3 Other Blood-Testing Startups: 7SBio
Seventh Sense BiosystemsTouch-Activated Phlebotomy Device Name: Seventh Sense BiosystemsTechnology: Seventh Sense Biosystems (7SBio) has developed an at-home blood testing device using its proprietary Touch-Activated Phlebotomy technology. The device ...

Heard About Theranos? Here Are 3 Other Blood-Testing Startups: Spot On Sciences
Spot On SciencesHemaSpot Name: Spot On SciencesTechnology: The HemaSpot technology from Spot on Sciences uses a finger stick to collect two drops of blood at home or anywhere else, and dries the bloodThe drying is performed within the cartridge using ...

Heard About Theranos? Here's 3 Other Blood-Testing Startups
Arundhati ParmarIf you hadn't heard about Theranos, the disruptive blood-testing company before, you probably do now after the recent scrutiny of its core technology and questions about its accuracy. Here's how the company is responding to those charg...

Heard About Theranos? Here's 3 Other Blood-Testing Startups: Tasso
TassoHemoLink Name: TassoTechnology: Similar to Seventh Sense Biosystems (7SBio) and Spot On Sciences, Tasso also has developed a device that allows people to take blood at home relatively painlessly.The HemoLink device uses microneedles and microflui...

Medtech Veteran: Innovation Has To Go Beyond R&D
The medtech industry is in the throes of a paradigm-shifting change, and a medtech veteran shares her thoughts on how to navigate them. Stacy Enxing Seng, former president of Covidien's Vascular Therapies Business UnitArundhati ParmarThe medtech indus...

Medtronic Questions Masimo Pulse-Ox Patents
Medtronic had been paying Masimo royalties for two pulse-oximetry patents held by Masimo. Now Medtronic is questioning the validity of those patents with the Patent Trial and Appeal Board of the USPTO.Qmed StaffMedtronic has filed a claim with the USPT...

New Plastics Adapt to Changing Medical Needs
Medical device manufacturers today demand plastics that are stronger, lighter, and more durable than ever before.Frank VinluanRTP Co. developed a proprietary plastic that, compared to currently available plastics, resists harsh chemical and cleaners u...

Ni-Ni and Thermocouple Sensor Wires in Multiple Configurations
Sandvik Palm Coast (SPC) is pleased offer single, dual, and multi-conductor configurations of Ni alloys for use as lead wires for thermistors and related sensing devices.  These “next generation” Nickel based leads offer the latest in precisio...

PFOA Free PTFE
Sandvik Bioline’s Sandvik Palm Coast (SPC) location is pleased to announce that SPC has extended its production capability for medical wire to include enhanced versions of PTFE coatings through using  proprietary processes that result in better...

Specialty Coating Systems to Promote Parylene Coatings for Medical Applications at MD&M Minneapolis
Specialty Coating Systems (SCS) announces that the company will exhibit in Booth #1017 at MD&M Minneapolis.

Why Size Matters When It Comes to Medical Devices
A one-size-fits-all approach can be dangerous for certain implantable medical devices. Qmed Staff"If it doesn't fit, you must acquit," defense attorney Johnnie Cochran told jurors in 1995, referencing the infamous bloody glove that would not fit on ac...

Will Neuro FDA Clearance for Medtronic's TYRX Envelope Lead to More Risk Sharing?
Marie ThibaultEarlier this month, Medtronic announced FDA clearance of the TYRX Neuro Absorbable Antibacterial Envelope to be used with implantable neurostimulators (INS). The product, a mesh envelope into which INS or cardiac implantable electronic de...

6 Advantages for Using Linux Embedded OS
QMED Independent Article on Linux OS

Abbott CEO: Emerging Markets Still a Good Bet
Jamie HartfordDespite warnings that overall growth in emerging economies is slowing, Abbott Laboratories chairman and CEO Miles D. White remains confident that these markets continue to offer plenty of opportunity for healthcare companies.During the t...

European Regulators Recommend Pulling Medtronic Implant from Market
The European Medicines Agency (EMA) has announced that it is recommending halting the sale of Medtronic's Inductos product. In the United States, the product is marketed as the Infuse Bone Graft, which has been the target of extensive litigation invol...

Expect Stryker to Acquire More Companies in 2016
Arundhati Parmar2015 has been a bit of a lull for Stryker when it comes to dealmaking, all the more striking given how the medtech industry overall has seen a flurry of mergers and acquisitions.The orthopedics company has acquired just two companies t...

How a Frankenstein Prototype Ended Up Being Worth $93M
Decades ago, a Case Western Reserve University professor had the idea for a more-precise alternative to the EKG. The technology formed the basis for the company CardioInsight, which was acquired by Medtronic earlier this year. Brian BuntzThe CardioIns...

Improvements Suggested on Eve of AccessGUDID Compliance Date
Marie ThibaultTomorrow, October 24, 2015 is the date makers of implantable, life sustaining or supporting devices must start linking device information, including the unique device identifier, to the AccessGUDID (Global Unique Device Identification Dat...

More Bad News for Breast Implant Company
Sientra's stock has slid more than 80% from highs of over $25 per share it hit this July and August. Now, the company has announced that a fire has hit one of its manufacturing facilities, operated by the Brazilian firm Silimed.Qmed StaffAn amateur pi...

Parallel Review Evolves: FDA Expands from Pilot to Considering Private Payers
FDA interest in involving public and private payers early in the review process may be very beneficial to medical device makers.Yarmela Pavlovic and Beth Halpern In 2010 FDA and CMS first announced an innovative program designed to decrease the time b...

Why Outsourcing Your Product Development Makes Sense
Earlier this year, Paul LaViolette, managing partner and chief operating officer of SV Life Sciences Advisers, a prominent life sciences venture capital company declared that contract product development would be a big outsourcing trend over the next ...

10 Scary Antique Medical Devices for Halloween
10 Scary Antique Medical Devices for Halloween With Halloween a little over a week away, we’ve rounded up 10 medical devices from yesteryear that will send a chill down your spine. Continue Learn more about cutting-edge medical devices at Minnesota Med...

9 Promising Cardio Technologies: Wireless LVADs
Wireless LVADsReliantHeart is developing a fully implantable version of its HeartAssist5 LVAD. Left ventricular assist devices (LVADs) have been one of the biggest advancements in heart failure to be commercialized in the last decade, but the therapy ...

Cardiac Company Turns to Bankruptcy
Cardiac Science Corp., which makes automated external defibrillators, has filed for Chapter 11 bankruptcy protection.Nancy CrottiCardiac Science is a maker of defibrillators like this one. A new board of directors has taken charge of Cardiac Science (...

Don’t Miss BIOMEDevice San Jose
The conference and expo heads to Silicon Valley December 2–3, 2015, and you won’t want to miss these opportunities at the event.Jamie HartfordSilicon Valley is home to the fourth-largest concentration of biomedical engineering jobs in the United State...

Fabrico Medical to Exhibit Advanced Medical Fabrication Capabilities at the 2015 MD&M Minneapolis Show
Fabrico Medical announces its participation in the 2015 MD&M Minneapolis Show, Booth #1416, November 4‐5, 2015, at Minneapolis Convention Center, Minneapolis, MN.

Regulatory Divisions Pressured by More Demands and Cost Cuts
Regulatory affairs professionals have the mounting pressures of revised regulations, more PMAs, IDEs, and change requests to contend with, but don't have the higher headcounts or larger budgets to match.Marie ThibaultMore work and fewer resources to do...

Was Medtronic Right About St. Jude Medical's CardioMEMS?
St. Jude Medical cuts its revenue expectation for its novel congestive heart failure management device. Did a Medtronic executive have it right when he described CardioMEMS as an expensive solution?Arundhati ParmarThe CardioMEMS congestive heart failu...

9 Promising Cardio Technologies
Heart disease kills one in four people in the United States, but these breakthrough technologies are aiming to change that.Heart disease kills well over half a million Americans each year, making it the leading cause of death in both men and women, ac...

9 Promising Cardio Technologies: Atrial Fibrillation 3-D Mapping and Imaging
Atrial Fibrillation 3-D Mapping and ImagingAcutus Medical's catheter, called "The Katheter," is part of a system designed to construct 3-D images and maps showing electrical activation in the heart.The success rate of catheter ablation procedures to t...

9 Promising Cardio Technologies: Better Monitoring Solutions
Better Monitoring SolutionsSt. Jude Medical's CardioMEMS HF System uses a wireless monitoring sensor implanted in the pulmonary artery (above) along with a portable electronic unit and pillow contaning an antenna to measure and transmit data about pat...

9 Promising Cardio Technologies: Improved Diagnostics
Improved DiagnosticsAbbott Laboratories's Architect Stat High-Sensitive Troponin-I (hsTnl) test could prevent unnecessary hospitalizations for patients who go to the emergency room with chest pain.Better diagnostics lead to better treatment, and with ...

9 Promising Cardio Technologies: Leadless Pacemakers
Leadless PacemakersBoth St. Jude's Nanostim (top) and Medtronic's Micra (bottom) leadless pacemakers have CE Mark approval. In comparison to traditional pacers, leadless pacers don't have transvenous leads, don't require surgery, are a fraction of the...

9 Promising Cardio Technologies: Noninvasive Assessment of Coronary Artery Blockages
Noninvasive Assessment of Coronary Artery BlockagesA sample simulated heart model from HeartFlow pinpoints a red artery as having a problematic FFRCT estimate of 0.58.To avoid over-stenting, physicians can determine whether a coronary artery needs to ...

9 Promising Cardio Technologies: Solutions to Prevent Surgical Site Infections
Solutions to Prevent Surgical Site InfectionsMedtronic's Tyrx Antibacterial Envelope prevents surgical site infections in patients implanted with a pacemaker or ICD.One of the biggest challenges of implantable device procedures is the potential for su...

9 Promising Cardio Technologies: Stroke Prevention Solutions
Stroke Prevention SolutionsClaret Medical's Sentinel Cerebral Protection System aims to reduce the potential for stroke in TAVR procedures.While physicians are slowly but surely embracing Transcatheter Aortic Valve Replacement (TAVR), the potential fo...

9 Promising Cardio Technologies: TMVR
Transcatheter Mitral Valve Repair and ReplacementEdwards Life Sciences recently bought CardiAQ Valve Technologies, which is developing a novel mitral valve replacement product (shown). Transcatheter mitral valve repair or replacement (TMVR) could be t...

Adverse Events Tied to First of Its Kind Spinal Device
Imagine you are working beneath a car and the car jack suddenly fails. Expandable (or telescopic) spinal implants for anterior cervical corpectomy can be compared to a car jack--when they collapse in the cervical spine, the consequences can be grave, ...

Hot Topics Make CDRH Regulatory Science Priority List
Marie ThibaultThis week, CDRH released its top priorities for regulatory science needs. CDRH describes this list as 10 equally important issues that were identified by the Regulatory Science Subcommittee (RSS) of the CDRH Center Science Council. CDRH's...

Shocking Mental Disorders Into Submission
Neurologists begin to explore targeted electrical brain stimulation to treat various mental disorders including obsessive compulsive disorder and even depression. Kristopher SturgisIn extreme cases, obsessive compulsive disorder (OCD) can be a very de...

Specialty Coating Systems to Host Webinar: Enhancing Medical Device Performance and Reliability with Parylene Conformal Coatings
– Specialty Coating Systems (SCS) announces that it will host an educational webinar entitled, “Enhancing Medical Device Performance and Reliability with Parylene Conformal Coatings”.

Supremes Take Stryker Case against Zimmer
The U.S. Supreme Court will decide whether Stryker Corp. will receive triple damages in a patent infringement suit against rival orthopedic device manufacturer Zimmer.Nancy CrottiA federal appeals judge ordered Zimmer in 2013 to pay $228 million to Str...

Theranos Strikes Back against WSJ at WSJ Event
Although $9B blood-testing firm Theranos has entered a "pause period" after a pair of Wall Street Journal articles questioned its technology, the company's founder Elizabeth Holmes is seeking to restore the firm's credibility by defending its technolo...

Can Brain-Interface Technology Rehabilitate Paralysis?
Brain-computer interface technology as a way to bypass spinal injuries -- permitting paralyzed patients to move their limbs through the use of an implant in the brain.Kristopher SturgisElectrodes used to stimulate muscles and create movement.Doctors f...

Collecting Reimbursement Data Alongside Clinical Data Is the Smart Road to Market
Waiting to consider reimbursement until after your device has secured regulatory approval can be expensive and time-consuming. Elizabeth BrooksA number of years ago, I was at a conference with a CMS official who told our group, “The FDA gives you perm...

Demand For Robots in Surgery Set to Increase
Arundhati ParmarSurgeons are more and more relying on robotic tools for surgery in the U.S.Research based on a survey of U.S. surgeons conducted by RBC Capital Markets show that in 2016, surgeons expect their robotic general surgery procedures to grow...

How to Cut Software-Related Medical Device Failures and Recalls
Medical device recalls nearly doubled from fiscal years 2003 to 2012, according to the FDA.1 While some attribute the spike to increased reporting on the part of device manufacturers, others blame design failure--in particular, software design failure...

Masimo CEO: Medtronic, Epic Refuse to Share Data
Masimo CEO Joe Kiani believes if medtech companies share their data it would help to reduce preventable deaths but some companies are refusing. Arundhati ParmarJoe Kiani, founder, CEO of Masimo Corp.For the past three or four years, Masimo CEO Joe Kia...

Theranos Turns to Silence as Controversy Unfolds
The curious case of Theranos raises questions not only about the former media darling but also about the rules that allowed it to share so little data with government regulators.Nancy CrottiThe $9-billion Silicon Valley startup that promised to perform...

What to Know about China's Fast Track Approval Process
Even if you're at a non-Chinese company, you can still take advantage of the China Food and Drug Administration's fast track approval process for innovative medical devices. An expert dispels common misconceptions about the process. Marie ThibaultMuch ...

AssurX Releases Audit Management Software Update
AssurX, Inc. announces the release of the latest update to their AssurX audit management software.

How Hackable Are Medical Devices?
As greater wireless functionality is incorporated into medical devices, the risk of security problems increases.Brian BuntzJay RadcliffeIn 2011, the software security expert Jay Radcliffe hacked his insulin pump on stage at the Black Hat security conf...

How to Pick Textiles for Implantable Devices: Infographic
Biomaterials specialist Proxy Biomedical Ltd. put together this infographic, which details important considerations when selecting medical-grade textiles for implantable medical devices.Click to expand image

Injured Device Patients Blitz CDRH’s Shuren
Injured patients have taken their demonstration to the email inbox of CDRH director Jeffrey Shuren.Jim Dickinson“Hey, hey FDA, how many people have you killed today?” Not since a chanting, angry crowd of hundreds of AIDS protesters blocked the street ...

Laser Microfabrication Takes on Diagnostic Consumables: Part 1
Advances in laser technology is leading to a wave of progress in diagnostic instruments. Glenn Ogura, Resonetics The trend to miniaturize diagnostic instruments leads to many benefits for patients and caregivers. It opens up opportunities for treating...

Medtech Industry Needs to Build Trust With Hospitals
A report from McKinsey & Co. states that medtech companies can get substantial benefits if they can build credibility among hospital customers. Arundhati ParmarA new report from consulting firm McKinsey & Co. shows that the medtech industry has a ways...

Minnesota Medtech Week Innovation Prize Finalists Announced
With more than 462 votes in, our readers have selected the five finalists for the Minnesota Medtech Week Innovation Prize.Qmed StaffFrom a novel method of "printing" electronics to an affordable, professional-grade desktop 3-D printer, there will be an...

New Exoskeleton Suit Aims to Help The Elderly Remain Active
An international team of researchers have developed a portable robotic exoskeleton device that could serve as tool to help elderly patients remain active. The exoskeleton could make it easier for them to take walks, lift, and carry objects, and improv...

The Digital Health Revolution Will Need To Wait...A Bit
There are real, practical concerns regarding digital health that will need to be ironed out before adoption can take place, says a well regarded cardiologist. Arundhati ParmarThe excitement around digital health is palpable and there are startups that...

FDA to Improve Combination Product Review Process
Marie ThibaultFDA has turned a critical eye on itself, examining its regulation of combination products—those that merge drugs, devices, and/or biologics—to find ways to make the premarket review process better. FDA's combination product review process...

Nov. 18-19, 2016 - Visit GRI at MD&M Florida – Orlando, FL – Booth 143
GRI is exhibiting at the Medical Design & Manufacturing Show in Orlando, Florida November 18-19. Visit Booth 143 where we will be showcasing the Integrity Series™ Magnetic Drive Pump Recirculation Pumps as well as other custom engineered pumps for the ...

Theranos Under Fire after FDA and Press Scrutiny
Theranos had been one of the hottest startups in Silicon Valley. Now the company is seemingly under attack, facing tough scrutiny from both FDA and several press outlets--most notably the Wall Street Journal.Qmed StaffOne of the hottest startups in Si...

There Will Be Blood
Diagnostics startup Theranos has been wowing investors and healthcare observers with its goal to disrupt the blood-testing industry, but now its core technology and practices are being questioned.Arundhati ParmarElizabeth Holmes, founder and CEO, Ther...

What Is Disruptive Innovation and Why You Can't Afford to Ignore It
For those of us in the medical device industry, attempting to predict when and where disruptive innovation will happen, can be baffling. Here are some pointers on how to identify what it is and how to actually create disruptive medical products.Craig ...

California Medtech Layoffs Approach 1200
Medical device companies--including some big names--have laid off nearly 1200 workers in California since July, according to a report by that state's Employment Development Department.Nancy CrottiIt's been a rough couple of months for many California-b...

FDA Inspectors Leave Calling Cards For Device Manufacturers Nationwide
Warning letters emphasize the importance of being able to generate and control adequate records when an FDA inspector comes for an inspection.

Fraud Allegations Surround Spinal Device Greenlit by FDA
Spinal implant firm NuVasive recently received 510(k) clearance for a spinal implant for cervical corpectomy, marking the first time that the agency had approved or cleared a medical device for this intended use. One of the predicate devices used to g...

In Drug-Coated Balloons, Medtronic Has the Edge Over C.R. Bard
Arundhati ParmarC.R. Bard may have been the first company in the U.S. to win FDA approval for its drug-coated angioplasty balloon catheter to treat peripheral artery disease, but Medtronic may be the one with the clinical edge.At the 2015 Transcathete...

Tegra Medical Wins ODT Advertising Award
Tegra Medical's marketing team is proud to announce that a recent print advertisement received Orthopedic Design & Technology's (ODT) Outstanding Advertising Award. This is a recognition of the advertisement that achieved the highest readership respons...

Telehealth to Get New CPT Codes
Marie ThibaultTelehealth is a rapidly growing area of healthcare, with regulators and legislators following the space closely. Now, the latest advancements in telehealth are gaining additional legitimacy as the American Medical Association (AMA) is wor...

The Neverending Search for Brain-Inspired Chip Technology
Scientists continue to make progress in the field of neural-inspired computer chips, which could ultimately lead to the development of novel neural networks and improve the treatment of traumatic brain injuries.Kristopher SturgisThe TrueNorth chip des...

Up to Code: Implementing a Quality System
A quality system can be a big help or a big headache. Here are tips on how to put the right quality system in place.Katherine CoxFor startup executives, quality systems can be a financial drain. When poorly implemented, they can even be an impediment ...

Who Are the Most Innovative Minnesota Medtech Week Exhibitors?
Our editors have picked the 10 semifinalists for the Minnesota Medtech Week Innovation Prize. Help us narrow down the group to five finalists.Chris NewmarkerFrom an affordable, professional-grade desktop 3-D printer to better coatings and materials to...

Are Digital Health Applications Really Fulfilling Clinical Needs?
Arundhati ParmarFamed cardiologist and digital health evangelist Eric Topol demonstrated the promise of digital health technologies exhorting his medical colleagues to embrace patient-generated data and adopt digital health technologies in their clini...

Boston Sci Transvaginal Mesh Verdict Cut
Marie ThibaultIn May 2015, a Delaware state court ordered Boston Scientific to pay $100 million in damages to a female plaintiff that a jury found was injured by the company's transvaginal mesh products. That was seen as a tremendous victory for the pl...

Fantastic Voyage: MEMS Sensors for Biomedical Device Applications
MEMS are helping to advance biomedical devices by leaps and bounds, but technical and business challenges remain.Charles Chung, Ph.D.Shown are different pressure sensor designs—each tailored to customers' neeeds—on a single RocketMEMS semicustom wafer...

FDA Wants to Be First in the World to Approve Devices
CDRH's vision is for U.S. patients to have access to safe and effective medical devices before other countries. Brian BuntzShuren announced that the agency had made substantial progress in terms of its timelines of approving 510(k)s, PMAs, and de novo...

J&J Hints at How Google Partnership Will Disrupt Surgical Robotics
Jamie HartfordJ&J hopes the surgical robotic system it's developing in partnership with Google will be smarter, smaller, and cheaper than current models, such as Intuitive Surgical's da Vinci Xi (shown here).Smarter, smaller, cheaper. In a nutshell, t...

The Makings of a Medtech Pioneer: John Abele
This week in San Francisco, Boston Scientific co-founder became the first non-physician to receive the TCT Career Achievement Award.  Brian BuntzJohn AbeleJohn Abele's accomplishments in the medical device field are almost too many to count. The co-fo...

Why Smith & Nephew Is Shy of Megamergers
The British medical device giant's CEO recently shared some of his skepticism with The Financial Times. Qmed StaffSmith & Nephew CEO Olivier Bohuon is not only wary of a merger with another huge medical device company, but considers such speculation as...

A Hidden Benefit of Humans Factors Studies
Human factors studies can be a chance to set your company’s device apart from the competition. Here’s how one human factors study did just that. Marie ThibaultGlucagon Nasal Powder (GNP) is in Phase III clinical trial testing to treat severe hypoglycem...

A Major Breast Implant Scare Is Now a U.S. Problem
Worries involve breast implants that Brazilian contract manufacturer Silimed made for Sientra.Nancy CrottiSientra has halted U.S. sales of breast implants made by contract manufacturer Silimed, following suspension of sales by regulators in Brazil, th...

Cirtronics Contract Manufacturing Gains Certification from WBENC

HeartWare Faces Problems with Its MVAD
A clinical trial of HeartWare's newest LVAD has been paused, at the same time that St. Jude Medical's HeartMate 3 has won CE Mark.HeartWare's MVAD is one-third the size of its HVAD pump. (Image courtesy of HeartWare)Nancy CrottiHeartWare International...

HeartWare: MVAD CE Mark Trial May Be Further Delayed
Marie ThibaultHeartWare's MVAD was being studied in a CE Mark trial that was paused in September.Just a day after competitor St. Jude Medical announced CE Mark approval for its next-generation HeartMate 3 left ventricular assist system (LVAS), HeartWar...

New Product from Medtronic Aims to Reimagine the Coronary Stent
Arundhati ParmarMedtronic is trying to imagine a new design for the drug-eluting coronary stent.Drug-eluting coronary stents typically use polymers and new generations of drug-eluting stents often have bioresorbable polymers, or bioresorabale scaffold...

New Sensor Technology Promises More Successful In Vitro Fertilization
A pH sensor can optimize the chances of couples having a live birth via in vitro fertilization.Brian BuntzThe in vitro fertilization market is growing at a healthy rate, driven in part by falling fertility rates. From Japan to Western Europe to the Un...

ThermaPress is the newest addition to the Thermex Thermatron line of heat sealing systems.
ThermaPress is the newest addition to the Thermex Thermatron line of heat sealing systems. This thermal press system is designed for welding, sealing, and bonding thermoplastic materials not compatible with radio frequency (RF) or are too large for so...

Abbott’s Fully Absorbable Scaffold Not Worse Than DES, But Is that Good Enough?
Arundhati ParmarThe pull and push between an early, highly anticipated first-generation technology not approved in the U.S., and the need to demonstrate clear clinical benefits that is the basis of value-based care were on full display at the second d...

CE Mark for HeartMate 3 as MVAD Trial on Pause
Marie ThibaultSt. Jude Medical's HeartMate 3 has received CE Mark approval.Fresh off closing its acquisition of left ventricular assist system (LVAS) maker Thoratec, St. Jude Medical has announced that the HeartMate 3 LVAS has received CE Mark approval...

Getting Started on Medical Device Cybersecurity
Tackling cybersecurity in medical devices can be intimidating, leaving manufacturers overwhelmed and wondering where to start.Stephanie PrestonThe security of medical devices is an issue that has the industry’s attention. On October 1, I had the pleas...

Micropoc-pro
Carclo Diagnostic Solutions Ltd (“CDS”) to publish the first detailed test results from its development of the Micropoc-pro platform.

Next Generation LVAD Receives CE Mark
The HeartMate 3 uses magnetic levitation of the device's rotor to prevent trauma to blood passing through the pump--a problem with previous models.Chris NewmarkerThe HeartMate 3 should hopefully address some of the problems such as pump thrombosis see...

The Top 10 Cardio Device Companies: Highlights from TCT
Cardiology remains the second-biggest medical device area by sales, with just under $42 billion in sales in 2014, according to EvaluateMedTech. More than one in every 10 medical devices sold is a cardiovascular device. The sector has good prospects fo...

This Is How You Solder Tiny Catheter Coils
How did Classic Coil Co. solve a manufacturing challenge related to tiny copper wire coils for catheter tips? It came down to three words: trial and error.Chris NewmarkerThe tiny copper catheter tip coils look like brown fleas when lined up next to a ...

To What Extent Will Medical Devices Replace Doctors?
From automated anesthesia systems to apps that promise to detect skin cancer, the use of artificial intelligence for clinical applications is steadily growing by the day, leaving observers to wonder what the role of clinicians will be in the years to ...

6 Advantages of Linux for Medical Device Applications
Linux is gaining ground in the medtech sector. Here are six reasons why .Brian BuntzThe number of computers running Linux is steadily growing. Android, the most popular mobile operating system is based upon the Linux kernel. And the operating system i...

9 Devices that Show the Promise of POC Diagnostics
A host of technologies—from smartphones to lateral-flow strip analyzers—are coming together to make point-of-care diagnostics smaller, faster, and more convenient, as these nine devices show.Sherree GeyerSmartphones, biosensor strips, hand-held device...

9 Devices that Show the Promise of POC Diagnostics: Abbott's i-STAT System
Abbott's i-STAT SystemThe i-STAT System, from Abbott Laboratories (Abbott Park, IL) conducts blood analysis at the POC by combining the i-STAT handheld device with single-use i-STAT test cartridges. Two or three drops of blood applied to a single test...

9 Devices that Show the Promise of POC Diagnostics: Columbia University Dongle
Columbia Unviersity DongleEngineers at New York’s Columbia University piloted in Rwanda a smartphone accessory that uses disposable plastic cassettes with preloaded reagents to perform triplexed immunossay tests for sexually transmitted diseases, incl...

9 Devices that Show the Promise of POC Diagnostics: First Automatic
First Automatic includes a safePICO syringe to deliver a clot-free, homgeneous sample free of air contaminants and with an integrated needle shield to protect against needlestick injuries. The safeTIPCAP removes air bubbles and seals samples, register...

9 Devices that Show the Promise of POC Diagnostics: LamdaGen Plasmonic ELISA
LamdaGen Plasmonic ELISANeed central-lab-grade quantitation for high-speed immunoassays? LamdaGen developed a nano-based technology for mobile and POC diagnostics. The company’s single-step, high-sensitivity immunoassay is precisely quantitative in th...

9 Devices that Show the Promise of POC Diagnostics: Magnia Reader
Lightweight and portable, the battery-powered device provides three-second reading, repeatability better than 2% and works with Magnia CRP. A biomarker of inflammation, it provides 10-minute incubation and three-second reading time with an assay range...

9 Devices that Show the Promise of POC Diagnostics: RapiPlex
Cartridges with conjugate and membrane pads allow whole-blood and saliva collection, filtration, and dispensing, with quantitative results delivered in five and 15 minutes. Twelve analytes can be performed simultaneously.          Continue on to "7 Ap...

9 Devices that Show the Promise of POC Diagnostics: SNAP Pro Mobile
SNAP Pro MobileSNAP Pro Mobile, by IDEXX (Westbrook, ME), electronically screens for feline and canine heartworm, Lyme disease and anaplasmosis, ehrlichiosis, and other pathogens in 10 minutes at the POC. Able to read blood samples applied to plastic ...

9 Devices that Show the Promise of POC Diagnostics: Solo Step Heartworm Test
Solo Step Heartworm TestIn this veterinary diagnostic, lateral-flow immunoassays detect heartworm antigens and antibodies in serum, plasma, and anticoagulated whole blood in a single test. Solo Step CH and Solo Step FH heartworm tests from Heska (Love...

9 Devices that Show the Promise of POC Diagnostics: XCR DX Portable Diagnostic System
iver sub-15-minute diagnostics with actionable results in six to eight minutes. Patented XCR-detection chemistry combines with a reagent system that uses rapid sample preparation and amplification to deliver rapid results. CEO Bill Olson says his tech...

Biocompatibility Is Dead, Long Live Biocompatibility
According to Mike Drues, mere biocompatibility is just a description for a material that can be implanted in your body without killing you. Len Czuba begs to differ, finding that the standard he has worked his whole life to uphold is not a notion that...

Boston Scientific Reveals Its Interest in Mitral Valve Replacement
Boston Scientific has invested in an Israeli mitral valve replacement company since 2012, but only revealed it on Thursday after pumping new money in it.Arundhati ParmarBoston Scientific has had an interest in a mitral valve company since 2012, but on...

Could These New Flex Batteries Create Better Wearables?
A young Maryland company has zinc-carbon flexible batteries in development that are safer next to the skin.Chris NewmarkerSafe, quality batteries are one of the major design challenges facing developers of mobile health sensors. FlexEl, which develops ...

Philips Hooks Up with Amazon to Host Medical Data in the Cloud
The Netherlands-based tech giant continues to break down the traditional boundaries between the medical and consumer sectors.Qmed StaffPhilips apparently wants to be known as a medical technology trailblazer, leveraging consumer tech for healthcare app...

Regulatory Tips for IoT Device Developers
It's predicted that more and more device makers will add connectivity to medical devices. Here are some regulatory factors to consider as the Internet of Things sweeps the medtech industry.Marie ThibaultBy now, medical device developers know that the I...

What Will the Medtech Market Look Like in 2020?
A new report from Evaluate Medtech shows how the medtech market is evolving, which companies will dominate, and which market segments will command the most revenue. What does Medtech Market Look Like in 2020? | Create your own infographics[Photo Credi...

5 Opportunities for Mobile Health Apps
While mobile health apps have been around for some time, they have yet to find widespread use for managing serious health problems. Expect that to change. Juned. A. GhanchiHealthAssist is one of the apps developed by IndianAppDevelopers Co.  Since the...

Does Your Company Have the Right Culture to Innovate?
A company's culture is paramount to its success at innovation. What are those unwritten rules that define a company and how can they be recreated to encourage innovation?Ted Harro Maybe you scratch your heads sometimes, wondering why the flow of new i...

Lawsuit Against Starkey Seeks $11M in Damages
Starkey's former operations vice president, Keith Guggenberger, accuses his former employer of spying on him, defamation of character, and breach of contract.Nancy CrottiEven step-blood is thicker than water.That's what a recently fired executive alleg...

New Formlabs 3-D Printer Takes on Medical Prototyping
Formlabs officials think their new Form 2 stereolithographic 3-D printer could enable better medical device prototyping. Check out video of them demonstrating the printer at MD&M Philadelphia.Chris NewmarkerFormlabs--the four-year-old 3-D printer compa...

St. Jude Closes on $3B Thoratec Buy
The deal helps round out St. Jude's menu of heart failure devices and services. HeartMate II, as shown on Thoratec's websiteChris NewmarkerSt. Jude Medical has closed on its acquistion of major LVAS maker Thoratec, St. Jude said Thursday.The deal came...

Tips for Getting Your Device into a Hospital
Trying to get your new medical device picked up by a major hospital? Here are some insider tips for getting a foot in the (operating room) door.Marie ThibaultYour medical device has made it through all the early hurdles: design, user experience, clinic...

Why Device Designers Need to be Subversive
To innovate at large companies, proponents of user-centered design need to go off the radar and develop a solution that meets the needs of the business while delivering something management never could have imagined. Shana LeonardMedical device design...

Contract Manufacturers Step Up to Meet Evolving Medtech Needs
As the medical device industry consolidates, so is the supply base serving them.Devicix's offerings include its mHealth Gateway, which the company touts as providing cloud connectivity to a wide array of wireless medical health applications. Now part ...

Here's a Bit of Good News For Medtech Startups
Large, public medtech companies are spending less money on repurchasing shares than they used to, preferring to allocate cash to acquisitions and R&D.Arundhati ParmarHere's a bit of good news for medtech startups (and also for innovation). Large, publ...

How to Make Flexible Electronics Stick
Skin interface and adhesives present a major design opportunity for flexible electronics pioneer MC10 and others.Chris NewmarkerMC10 has technology for flexible, stretchable electronics. (Photo courtesy of MC10)When it comes to designing flexible elec...

St. Jude Fires Back on CardioMEMS Cost Criticism
Jamie HartfordSt. Jude Medical hails its CardioMEMS HF System as way to reduce hospital admissions and improve the quality of life for patients with moderate heart failure, but critics have charged that the device is too expensive. Today at the AdvaMe...

Top Orthopedic Firms and Trends From 2014 to 2020
The orthopedic industry will likely see some significant changes over the next few years. Here are some of the key trends facing the industry, and a brief overview of which companies are leading now, and which are projected to lead in 2020. Kristopher...

Wearables Must Answer the 'So What?' Question
Large volumes of raw data with no insight may actually hinder adoption of wearables and digital health technologies. Arundhati ParmarThere's one thing that developers of any new technology, and especially clinical wearables technology must avoid doing...

5 Predictions for Medtech in 2020
EvaluateMedTech recently released a report projecting where the medical device industry will be in 2020. While the report also reflected on trends like the dwindling amount of VC cash being invested in medtech and the gradual improvement of the regula...

Blurred Lines: Big Pharma's On-Again Off-Again Relationship with Medtech
The boundaries between the traditional drug and medtech realms are gradually eroding, being redrawn, and then eroding again.Brian BuntzEG-GILERO developed a Local Anesthetic Delivery System for Anutra Medical that launched in 2015. The product was nam...

FDA Orders More Studies of Duodenoscopes
The agency wants the three makers of duodenoscopes in the U.S.--Olympus, Fujifilm, and Hoya (Pentax)--to conduct postmarket surveillance studies.Nancy CrottiFDA has ordered the three companies that sell duodenoscopes in the United States to study how t...

FDA Quietly Proposes Change to Intended Use Rule
Device makers will want to be aware of one sentence omitted from a proposed rule about tobacco products.Marie ThibaultUnsurprisingly, MD+DI focuses mainly on medical devices and diagnostics. So it was a surprise to learn that FDA’s wording choices in a...

FDA Wants Postmarket Studies on Scopes
Marie ThibaultFDA continues its scrutiny of duodenoscopes with a request for postmarket study plans from the three manufacturers of duodenoscopes used in the United States. Olympus America, Inc, Fujifilm Medical Systems, USA, Inc., and the PENTAX Life ...

J&J Device Chief: The Days of Selling an SKU and Getting Paid are Changing
The worldwide chairman of Johnson & Johnson's medical devices business underscores how the world of healthcare purchasing is beginning to shift. Arundhati ParmarGary Pruden, worldwide chairman, Johnson & Johnson Medical DevicesThat the device industry...

2015 Medtech Company of the Year Finalists: Dexcom
Coming off a stellar year in 2014, during which its share price jumped by more than half over the previous 12 months, Dexcom has continued on an upward trajectory in 2015. In January, the San Diego-based maker of continuous glucose monitoring (CGM) de...

2015 Medtech Company of the Year Finalists: HealthSpot
HealthSpot has developed the primary care physician’s office of the future. The Dublin, OH-based company’s kiosks combine medical devices and telehealth to provide a walk-in clinic where patients can quickly be evaluated for common conditions such as ...

2015 Medtech Company of the Year Finalists: IBM Watson Health
There is an increasing recognition now more than ever before that healthcare is all about the data. And perhaps no other company understands the weight of that comment, its power, and its opportunity than IBM Watson Health. Launched in April, the busi...

2015 Medtech Company of the Year Finalists: Medidata Solutions
Medidata may not yet be a household name, but with its impressive history working with the heavy hitters in the medical field, you can bet many healthcare executives know it well. Founded in 1999, Medidata is the top provider of software and analytics...

2015 Medtech Company of the Year Finalists: Medtronic
In a big year that started off with the completion of its megamerger with Covidien, Medtronic continued its bold march into the future. The Ireland-based device maker doubled-down on its pivot to a services model with moves like its April purchase of ...

2015 Medtech Company of the Year Finalists: Omada Health
Omada Health has been leading the “digital therapeutics” space. This new area of healthcare was created to help a vast number of people reduce their risk for chronic diseases that can be addressed by behavioral and lifestyle changes. Omada Health’s fl...

2015 Medtech Company of the Year Finalists: ReShape Medical
Obesity is a health challenge for millions of Americans, but until recently, there have been few therapies and no non-surgical treatments available for these patients. Several companies have been chasing FDA approval for a device treatment that does n...

2015 Medtech Company of the Year Finalists: Theranos
Theranos has been making waves for a few years, but the company known for its finger-prick diagnostic tests has taken major steps in 2015 to bring the technology to the masses. Since lab tests spur much of the clinical decisions made today, access to ...

2015 Medtech Company of the Year Finalists: Vote

A New Cathode Material Lays Groundwork for Sodium-Ion Batteries
Researchers from the University of Texas believe they have identified a novel safe and sustainable cathode material that could serve as the basic structure for the world's first commercially viable sodium-ion battery. Kristopher SturgisThe new cathode...

Cardinal Health to Buy Cordis for $2 Billion
Johnson & Johnson continues to slim down its medical device business, selling off its division that helped first bring drug-eluting stents (DES) to the market. Qmed StaffJohnson & Johnson had spent decades building up its medical device business, event...

FDA Approves 1st Bioresorbable Stent Made By Boston Scientific
Arundhati ParmarThe Synergy Stent from Boston Scientific now has both FDA approval and CE Mark in Europe.Boston Scientific announced on Monday that FDA has approved the first bioresorbable polymer stent - the Synergy - to treat coronary artery disease...

FDA Warns St. Jude over CardioMEMS Manufacturing
Most of the problems FDA brought up over St. Jude Medical's Atlanta facility have been addressed, the company says.Nancy CrottiFDA has sent St. Jude Medical (SJM) a warning letter about the company's corrective and preventive action plans for the manuf...

One Component, Neutral Curing Silicone Passes USP Class VI and ISO 10993-5 Tests
Specially formulated for medical device applications, Master Bond MasterSil 912Med is a room temperature vulcanizing silicone system for high performance bonding, sealing and coating. 

What the Future Looks to Life Sciences Instrument Makers
A recent survey of 302 life science instrument makers and users were given the opportunity to select the technologies that could most benefit their industry. Respondents also weighed in on key trends, including how they are dealing with regulatory and...

2015 Medtech Company of the Year Finalists
 There's never a dull day in the world of medical technology. This year, large companies continued last year's buying spree and many technology players jumped into healthcare by signing partnerships or announcing new business divisions. Companies cont...

A Fraud Lawsuit Could Establish Free Speech Rules for Medtech
With U.S. medical device executives facing prison time over their marketing, a constitutional challenge is being mounted against FDA's powers. Qmed StaffPatrick Fabian (left) and William Facteau were executives at Acclarent. It is very possible that ...

Creative or Fraudulent? How Acclarent Made Sinus Balloon Tech Worth $785M
In a legally murky but highly lucrative environment, former Acclarent execs were growing the company into a company that would become attractive enough that Johnson & Johnson would acquire it for $785 million. Based on history, it was probably hard fo...

Excellent Service by Stepping Back?
CDRH is getting high marks for excellent customer service, but at the same time, some stakeholders say their concerns are met with what they feel are dehumanizing, automatic responses.Jim Dickinson“I’m from the government and I’m here to help” is one ...

FDA Enthusiastic about Mobile Health Data
Marie ThibaultEven though FDA has issued guidance on mobile medical applications, many people in the field of wearables, remote monitoring technologies, and mobile health apps are still unsure of the regulator's take on specific requirements. So it was...

FDA Sends St. Jude Medical a Warning Letter Over CardioMEMS
Arundhati ParmarFDA has sent St. Jude Medical a warning letter regarding its manufacturing plant in Atlanta which makes the CardioMEMS device, the Minnesota company disclosed Friday.The agency faults the company for not following good manufacturing pr...

Move to 3.0 T MRI Spurs Cochlear Implant Innovation
How Med-El designed the first FDA-approved cochlear implant that's conditionally safe for use with high-resolution 3.0 T MRI without requiring surgical removal of the internal magnet. Martin ZimmerlingMed-El's Synchrony cochlear implant received FDA a...

Nelson Laboratories Celebrates 30 Years Supporting Life-Saving Medical Device Innovation
2015 marks the 30th anniversary of Nelson Laboratories’ founding. A world leader in the medical device testing industry, Nelson Labs is a microbiology testing and consulting services organization serving medical device, pharmaceutical, tissue, and life...

Telesis Technologies, Inc. Proudly Introduces the NEW NOMAD 4000 Portable, Rechargeable, Battery Powered Hand-Held Marking System
Telesis Proudly Introduces the NEW NOMAD 4000 Portable, Rechargeable, Battery Powered Hand-Held Marking System

A Smart Mouth Guard to Track Health Markers in Real Time
Engineers at UC San Diego have built a mouth guard prototype that can monitor health markers such as lactate, cortisol, and uric acid. The technology is designed to transmit health tracking information wirelessly in real time to any smartphone, laptop...

Is Apple Developing a Smart Ring?
A newly filed patent application suggests that the high tech giant is at least considering the possibility.Chris NewmarkerDrawings of a possible wearable ring device, included with the Apple patent applicationWhy monitor health with a smart watch when...

Nominate Medtech's 2015 Supplier of the Year
Know a medical device and diagnostic industry supplier that went above and beyond this year? Nominate them for Medtech Supplier of the Year.Advances in medical technology would not be possible without the suppliers who provide the services, equipment,...

Philips, MIT Want to Transform Brain Injury Monitoring
The goal is create a noninvasive way to measure intracranial pressure.Chris NewmarkerPhilips envisions its mobile ultrasound technology helping to non-invasively determine brain injuries. (Image courtesy of Philips)Philips and MIT have forged a partne...

Sci-Fi Technologies Coming to a Medical Device Near You
Science fiction continues to help drive advances applicable to the medical field as well. Below are several science fiction-inspired technologies that could be the next to break into medtech, which are also detailed in our infographic on the subject.V...

UPS Creates New Medical Device Distribution Hub
The 208,000-square-foot facility is in New Jersey, near UPS's air hub at Philadelphia International Airport.Chris NewmarkerUPS this week announced the opening of a new healthcare-compliant distribution and warehousing facility in New Jersey.The 208,000...

Who Will Be the No.1 U.S. Spine Market Share Gainer in Next 12 Months?
The U.S. spine market is improving, so which company is poised to win in 2016?Arundhati ParmarThe U.S. spine market is improving with fewer lumbar procedures being delayed compared to previous years, increasing surgeon backlog of procedures and a stab...

Alpha Wire Introduces Brass Braid Sleeving to the FIT Wire Management Family
Elizabeth, NJ, September 30, 2015 – Alpha Wire has added brass braid expandable sleeving to its FIT wire management portfolio.  FIT Brass Braid Sleeving is not only nice to look at, but also features a tough exterior that provides great EMI protec...

FDA Touts Improved IDE Review Stats

Glucose Monitoring Market Tops $10 Billion
The global glucose monitoring and diabetes management market is worth $10.03 billion in 2015, according to a new report. An aging population with higher healthcare needs along with avaliability of new continuous glucose monitors and sensors is drivin...

Hackers Flock to Fake Medical Devices
Marie ThibaultResearchers have shown, through an experiment, that medical devices are available to hackers. According to tech news outlet The Register, security experts this week said that software they used to imitate two devices, an MRI and a defibri...

How Mobile Health Data Can Boost Traditional Medtech
The wearable trend doesn't need to be viewed as a threat. One medtech veteran explains how traditional medtech manufacturers can benefit, even thrive, as a result of mHealth data.Marie ThibaultOftentimes, new technologies are viewed as disruptors that ...

Keeping Up With Advances in Electronics
Technological advances are opening up a whole new world for medical electronics designers. Jamie Hartford The world’s smallest pacemaker, smart contact lenses, medical devices with embedded vision—none of these technologies would be possible without ...

Kenmode Expands Metal Stamping Capabilities with New Tech Center
Kenmode has opened a 20,000-square-foot Tech Center for the rapid development and prototyping of new precision metal stampings.

Nanoparticles Masquerading as Blood Cells Boost Drug-Delivery Precision
Nanoparticles disguised as human platelets could open the door for targeted drug treatments for cardiovascular disease and various bacterial infections. The technique is expected to greatly enhance the healing power of such treatments without saturati...

Qosina Breakable Male Luer Lock Connector
Qosina is pleased to announce the addition of a new breakable male luer lock connector (#11759), in stock and ready for immediate delivery.

Steris Settles Lawsuit over Tax Reimbursements to Executives
The reimbursements involve Steris' upcoming $2 billion acquisition of medical device sterilization rival Synergy.Chris NewmarkerSteris has settled a shareholder lawsuit filed over special payments its board approved for top officers and directors--paym...

What Crowdsourcing Can Do to Help the Disabled
Some of the most promising technologies developed at a recent Google.org-supported makeathon have been uploaded to MakerBot's Thingiverse, inviting tinkerers from around the world to improve and customize the plans. Brian BuntzGoogle's philanthropic a...

When Is Off-Label Promotion a First-Amendment Right?
Medtech executives charged in two high-profile criminal cases are making the argument that FDA is squelching their free speech.Qmed StaffVascular Solutions CEO Howard Root (left) and Patrick Fabian, currently chief commercial officer at NxThera, are a...

7 Crime Stories You Have to Read to Believe
The medical device industry is unfortunately crime blotter worthy. Here are seven recent cases to make the headlines.Chris Newmarker and Brian BuntzMedtech unfortunately has its share of crime cases, as we've come to discover at Qmed. In this year alo...

Cleveland Clinic Clashes With Ortho Surgeon
Arundhati ParmarEarlier this month, Dr. Raymond Horwood, an Ohio orthopedic surgeon, created a bit of a stir when his practice sent a letter to patients informing them that he was moving his practice from Cleveland Clinic's Fairview Hospital to anothe...

Device Makers Take Note: Cyber Attacks Are Already Hitting Healthcare
Find out why some medical device manufacturers aren't adequately protected against cyber attacks and what companies can do to increase cybersecurity.Marie ThibaultCyber attacks aren't merely a threat of the future for healthcare companies and hospitals...

Surgeon Gets Prison Time for $7M Medtech Fraud Scheme
A former Army surgeon was handed a nearly three-year sentence for accepting fraudulent payments from medical device companies. Brian Buntz and Chris NewmarkerFormer Army Lt. Col. Richard Craig Rooney, 46, is going to prison for failing disclose his fi...

What Other Companies Could Medtronic Buy With its War Chest?
Medtronic has been gobbling up companies and technologies in the past 15 months and the pace may quicken further. What companies could be in its radar? Arundhati Parmar On Monday, Medtronic took a $500 million charge recording a one-time income exp...

A Biomimetic Dental Material As Strong As Tooth Enamel
Swiss scientists have developed a technique that enables them to imitate miniature geometries found in biological composites with teeth and seashells. The breakthrough could ultimately lead to the development of synthetic materials with strength compa...

Do You Really Understand the Problem You're Trying to Solve?
If I were to tell you it's important to understand a problem before you start trying to solve it, you might reply with something like "nice one, Einstein" (sarcastically, of course...). Well then, did you know that one of the most common failures of e...

How a Doctor Saved a Child with a MacGyver Medical Device
A robotic surgeon got creative rigging together ordinary objects into a nebulizer when a child suffered an asthma attack on a transatlantic flight.Khurshid Guru, MD, and his do-it-yourself nebulizer. (Image courtesy of Guru)Brian Buntz and Chris Newma...

Is Medtech Still a Good Career Choice?
Medical device and diagnostic companies have traditionally offered higher-than-average salaries and growth prospects, but is medtech still a good industry in which to stake your career? Jamie Hartford Each year when we conduct our Medtech Salary Sur...

Medtronic Buys Clot Removal Company Lazarus Effect for $100M
Medtronic announced Monday that it has bought Lazarus Effect, a Campbell, California company that has developed products to treat ischemic strokes for $100 million in cash. Lazarus Effect has a  "mesh cover" technology that helps in the capture and r...

More Limits for Bayers' Controversial Essure Device?
Some women are less suitable for the Essure device, according to an FDA panel, which examined thousands of complaints over the past decade.Chris NewmarkerA U.S. FDA advisory panel is recommending more limited use of Bayer's Essure contraceptive device ...

NeuroSigma Withdraws IPO Plans
NeuroSigma, an epilepsy treatment company, has withdrawn its plans for its initial public offering through which it was expecting to raise $50 million. On Friday, the Los Angeles company quietly pulled back its regisration statement with the Securit...

Smoothing the Flow of Valve Selection
Frank VinluanQosina supplies check valves, which may be normally closed but open when fluid in the line reaches a certain pressure.When the movement of gas or fluid must be regulated by a medical device, that control is typically managed by a valve. B...

What You Need to Know about the ISO 9001:2015 Revision
The International Organization for Standardization has released its 2015 revision of the ISO 9001 quality standard. Check out all the major changes here.Marie ThibaultThe ISO 9001 quality management system standard has been revised and published by the...

10 Medical Devices That Pushed Design Boundaries
10 Medical Devices That Pushed Design BoundariesSeptember 28, 2015A handful of medical device designers are helping the industry rethink what is possible when it comes to the design of medical technology. This year even marked the first time that a med...

AdvaMed CEO Leaving to Lead PhRMA
AdvaMed has started a nationwide search to replace Stephen Ubl, who has been the medical device industry group's CEO for 10 years.Chris NewmarkerStephen UblStephen Ubl is stepping down as AdvaMed's president and CEO, effective October 15, as he prepar...

AdvaMed Makes it Official CEO is Leaving
Stephen Ubl, who has led the medical device industry's largest and most influential lobby group, is jumping ship to lead a pharma trade association. Arundhati Parmar After initially declining to comment on rumors of its CEO leaving, AdvaMed, the m...

Audit of Major Breast Implant Maker Leads to International Scare
The United Kingdom, EU member states, and other countries have suspended sales of products made by the Brazilian firm Silimed amidst an investigation into the safety of its products.  Qmed StaffA recent audit of the Brazilian company Silimed has trigg...

FTC Fails to Block $2B Steris-Synergy Merger
A U.S. federal judge's opinion suggests that x-ray sterilization might not be the next big thing for medical device sterilization--at least not for a while.Synergy Health's industrial x-ray sterilization facility in Daniken, Switzerland, is able to pr...

Getting IDE Approval Is Now Quicker than Ever
Marie ThibaultCDRH is getting faster on metrics that matter to medical device manufacturers, like shorter device review times. Now, the center has become even speedier on another measure—the time it takes to get an Investigational Device Exemption (IDE...

Heart Monitoring Goes Mobile
Frank Vinluan St. Jude Medical's CardioMEMS HF System uses a miniaturized wireless monitoring sensor implanted in the pulmonary artery (above) along with a portable electronic unit and pillow contaning an antenna to measure and transmit data...

Primatics marks 19 years in the High Precision Motion Industry

Scapa Healthcare Launches New Perforation Capability
Scapa Healthcare announces the launch of its new perforation capability for Scapa Soft-Pro® Silicone Gel adhesives. The new capability allows Scapa Healthcare to offer its strategic business partners an expansive range of skin friendly turn-key solu...

SCAPA HEALTHCARE LAUNCHES NEW PERFORATION CAPABILITY

A Tangled Web: The World of Synthetic Spider Silk
Who hasn't read a Spider-Man comic book and watched the web slinger save someone with his super strong homemade webbing? It turns out manmade silk that is stronger than steel is closer than we think. Jordan BrandesEngineered spider silk fibers wrapped...

Controversial Essure Device Gets FDA Scrutiny
Thousands of women have complained to FDA about abdominal pain, headaches, and other complications after having the Essure coils implanted in their fallopian tubes.Qmed StaffU.S. FDA's Obstetrics and Gynecology Devices Panel heard sometimes emotional t...

Got Patient Care Ideas? FDA Wants to Hear Them
The FDA announces its first Patient Engagement Advisory Committee.

How Telemedicine Can Bend the Cost Curve
Arundhati Parmar Telemedicine holds great potential as a way to treat and monitor patients effectively in the continuum of care as they move beyond the walls of a hospital into their home. An analysis by PricewaterhouseCoopers shows that it also has t...

Is AdvaMed's Leader Moving to a Pharma Trade Group?
Marie ThibaultMedia outlets are reporting that Ubl may be leaving AdvaMed to head pharmaceutical trade group PhRMA.Could the influential head of Advanced Medical Technology Association (AdvaMed), Stephen Ubl, be leaving the medical device manufacturer ...

The Best Places to Be a Med Device Engineer?
As our sister publication MD+DI proclaimed, the medtech job market is heating up, and the demand for good engineering talent is outstripping supply. While that is certainly good news, it is less clear where in the United States is the best spot to be ...

7 Key Changes in the New EU In Vitro Diagnostic Medical Device Regulation
EU regulatory requirements could soon become stricter for in vitro diagnostic medical devices (IVDs), which cover a range of products that can be used for diagnosis, therapeutic drug monitoring, disease screening, assessment of medical interventions, ...

Alpha Wire Gains ISO 13485 Certification for its Plant in Carson, CA
Alpha Wire has received ISO 13485:2003 certification for its Carson, California, manufacturing facility.  The certification encompasses the production, assembly, and quality control processes of wire and cable.  ISO 13485 is the leading quali...

Company Run by St. Jude Medical Founder Shuts Down
Former Kips Bay Medical CEO Manny Villafaña is on to his next venture. Manny VillafañaChris NewmarkerKips Bay Medical shareholders this week voted to dissolve the company after a disappointing clinical trial of its mesh "sleeve" meant to aid in in cor...

Device Firm Receives 1 of 18 FDA Grants for Orphan Product Development
Arundhati Parmar On Monday, FDA awarded 18 research grants totaling more than $19 million to promote the development of products to fight rare diseases. Only one of the 18 went to a device research project. A FDA spokeswoman clarified that typically ...

Ex Machina: What Is the Risk of AI in Medtech?
The recent film Ex Machina could serve as a warning for the unforeseen consequences associated with future medical technology.Brian BuntzAre we beginning to create a cloud-based healthcare monitoring network that is reminiscent of NSA's warrantless sur...

How Self-Driving Cars Can Steer Medical Devices to Success
Medical device engineers can take lessons from the development of automated driving and apply them to the quest for closed-loop devices for diabetes, neurological disorders, and more. Nigel Syrotuck On the street, the statistics are staggering: 35,00...

MD&M Minneapolis Highlights
Minnesota has long been the cradle of medical device innovation, and this year, during the state’s weeklong celebration of all things medtech, the MD&M Minneapolis conference and expo will roll into town with numerous opportunities for education and n...

PTI Engineered Plastics Technical Academy Earns Award
Mark Rathbone, CEO, honored by MISD

Seven Predictions for the European Medtech Market
Karen Simpkins and Ricardo VicenteThe medical device market in Western Europe will remain constrained by weakness in the eurozone, which is struggling to recover momentum, therefore non eurozone markets will record higher 2014-2019 CAGRs, led by the U...

How Makers Could Change the (Medtech) World
Medical device innovation is being democratized--at least for a handful of applications including prosthetics and diabetes monitoring technology. Brian BuntzLiam, then five years old, shows off his Robohand.Slowly but surely, the so-called Maker Movem...

Preparing for the Next-Generation of Healthcare Monitoring
AirStrip made waves earlier this month when it debuted its Apple Watch-compatible fetal monitoring technology. But in the words of the company's CEO Alan Portela: "This is not about an app. This is the next generation of monitoring."Brian BuntzThe deve...

These 5 Medtech CEOs Are the Most Underpaid
These 5 Medtech CEOs Are the Most UnderpaidChris NewmarkerSeptember 22, 2015Stryker CEO Kevin Lobo’s total compensation was 14th among top executives at 18 of the largest medical device companies publicly traded in the United States. But Stryker comes ...

10 Medtech Recalls that Shocked the Industry—Covidien Defibrillation Electrodes
A recall was initiated in September 2014 for Covidien defibrillation electrodes and electrodes made by Covidien and distributed by other brands. These electrodes are connected to automated external defibrillators to help shock the heart b...

10 Medtech Recalls that Shocked the Industry—Flexi-Seal CONTROL
In April 2014, a Class I recall of ConvaTec's Flexi-Seal CONTROL Fecal Management System Kit was announced. According to the FDA recall release, the company did not file for 510(k) clearance of the product. The device is intended to be us...

10 Medtech Recalls that Shocked the Industry—INRatio2 PT/INR Professional Test Strips
INRatio2 PT/INR Professional Test Strips In April 2014, Alere recalled its INRatio2 PT/INR Professional Test Strips because patients reported conflicting results between the INR measurements from the INRatio2 PT/INR Professional Test St...

10 Medtech Recalls that Shocked the Industry—Intra-Aortic Balloon Pumps
Maquet Intra-Aortic Balloon Pumps Some of the intra-aortic balloon pumps (IABP) made by Maquet Datascope Corporation were recalled in March 2014 because the device's fan assembly could malfunction and cause the device to stop with any al...

10 Medtech Recalls that Shocked the Industry—NaturaLyte
NaturaLyte Fresenius' NaturaLyte Liquid Bicarbonate Concentrate was recalled in April 2014 because of its potential to "develop higher than expected bacteria levels during its shelf life," according to the FDA recall release.  ...

10 Medtech Recalls that Shocked the Industry—Nephros Water Filtration
Nephros Water Filtration In October 2013, a recall of the Nephros SafeSpout, SafeShower HH, and SafeShower FH was announced. According to the FDA recall release, the filtration systems, used on sink faucets and shower heads, could expose...

10 Medtech Recalls that Shocked the Industry—Tiger Paw System II
Tiger Paw System II A recall of Maquet Medical Systems' Tiger Paw System II was announced in March 2015 after it was found that "incomplete closure" of the system could cause heart tissue tears and bleeding. The Tiger Paw Sys...

Convicted Murderer Drops Suit Against Boston Sci
Ramona Winebarger, who had been convicted of murdering her first husband in 1995, has given up her legal fight against Boston Scientific. The medical device company had planned to enter the murder conviction into evidence in the trial, arguing that it ...

Diabetes Device Wins Judges Over in 2015 Dare-to-Dream Medtech Design Challenge
A miniature diabetes device that helps to measure glucose continuously through tears while reporting results to a person's smartphone has won the 2015 Dare-to-Dream Medtech Design Challenge.The BlinkBit is a biosensor plug that is placed in the tear d...

Former St. Jude VP Turns Himself In over Theft Charges
Bryan Szweda is out on $100,000 bail. Bryan Szweda (Image via LinkedIn)Chris Newmarker A former St. Jude Medical vice president--accused of stealing nearly $142,000 via falsified expense reports and his corporate credit card--has traveled back to Minn...