• Big Device Companies See Opportunity for AI in Healthcare

    Major medical device companies are getting serious about the potential of artificial intelligence technology to improve patient care. Here’s Medtronic’s vision for using Big Data and IBM’s Watson to help diabetics.Brian Buntz    There is a growing trend of big device companies announcing partnerships with traditional tech companies. Take for instance Medtronic’s recent presentation at CES, where it showed off its plans to develop diabetes apps powered by IBM’s...
  • Medtronic Unveils Plan for Its Billions in Freed Up Cash

    Financial flexibility is the stated goal from Medtronic. Chris NewmarkerUpdated January 13, 2016The Covidien acquisition allowed Medtronic to access to 65% of its free cash flow, versus a previous 35%. (Chart courtesy of Medtronic)Medtronic announced this week that it will take the $9.3 billion in cash freed up from its mega merger with Covidien last year, and spend most of it on share repurchases and paying down debt.Wall Street appeared to have a ho-hum response to the news...
  • IVC Lawsuits Mount against CR Bard

    A growing number of patients are filing lawsuits against CR Bard, alleging that the company’s IVC filters are dangerous.Brian BuntzBoth CR Bard's Recovery and G2 filters (the latter is pictured here) were placed inside the placed inside the inferior vena cava to catch blood clots.There has been a considerable amount of negative news related to CR Bard’s vena cava filters on the heels of a year-long NBC investigation. Most recently, there has been an uptick in litigation...
  • Medtronic Leveraging IBM's Watson in Diabetes App: CES

    IBM and Medtronic look to combine powerful analytics and cognitive computing to develop a host of personalized diabetes management technologies.Kristopher SturgisMedtronic is working close with IBM's Watson unit. Here, Medtronic's Omar Ishrak shares the stage at CES with IBM's CEO Ginni Rometty. At CES, Medtronic shed light on its partnership with IBM’s newly formed Watson Health unit, which is seeking to bring innovative diabetes technologies to...
  • Essure PMA Was Fraudulent, Patient Group Says

    Members of the Essure Problems group, which has more than 25,000 members, contend that Bayer’s Essure birth control device is dangerous, ineffective, and was fraudulently brought to the market.  Brian BuntzDuring the clinical trial for Essure, Hudak had initially reported unusual health-related problems only have them crossed out at a later date.At a PMA meeting related to the Essure birth control device in 2002, one of the panel members, David B. Seifer, MD, asked what...
  • When Are 'Safe' Medical Devices Dangerous?

    No product can be 100% safe, but yet FDA’s mission with respect to medical technology is to ensure that devices are both safe and effective. Defining what exactly “safe” means, however, is no simple task.Brian BuntzAt MD&M West, Drues will be discussing reimbursement strategy and the regulatory strategy for 3D printed medical products in particular.Most of the criticism from patient advocates and some politicians concerning medical device industry or the FDA’s clearance of them is that...
  • Lawsuit Accuses Fitbit of Lying about Heart Monitor Accuracy

    Things might not be so rosy for Fitbit in 2016. The company’s stock tanked after its most recent product introduction and now the company is facing a class-action lawsuit alleging that its heart-rate monitors are inaccurate and, therefore, dangerous. Brian BuntzFitbit ad purportedly showing the device being used to monitor heart rate during a strenuous workout.A class-action lawsuit accuses Fitbit of lying about the accuracy of their heart-rate monitoring technology. The suit claims that...
  • 7 Things You Might Not Know About the Top Medtech States

    Did you know that California actually saw its number of life science industry employees rise by 2% during the Great Recession—or that Minnesota scores nearly twice as many medical device patents as Massachusetts? That’s just the tip of the iceberg when it comes to our extensive research into the top U.S. medtech states. (Image courtesy of NASA)Qmed Staff It is fairly common knowledge in the medical device industry that the three top U.S. hubs are in California, Minnesota, and...
  • Getting Revolutionary Devices onto the Market with Regulatory Logic

    While the FDA and regulatory bodies are constantly evolving, medical device technology is destined to evolve at a faster clip than regulatory code. What should medical device companies do?Brian BuntzAt MD&M West, Drues will be discussing the regulatory strategy for 3D printed medical products.The current regulatory structure of FDA or other regulatory bodies was not initially designed to accommodate personalized medicine in general or 3-D printing in particular. That doesn’t mean that...
  • First Blood-Pressure Wearable Launched at CES

    The Japanese electronics firm Omron is venturing into the wearables market with their new blood pressure monitor that looks more like a smartwatch than a medical device.Kristopher SturgisNearly 30% of Americans have hypertension and nearly half of those struggle to control their blood pressure. An important part of managing blood pressure is measuring it routinely, which can prove difficult for people on the go or at work. On top of that, the accuracy of blood pressure measurements can be...
  • Here's What the Top Medtech Firms Pay

    This year might be the best year yet for medtech job salaries—at least in the U.S. Here’s a look at salaries for key engineering and other jobs at the largest medical device companies, courtesy of Glassdoor.Qmed Staff (Money image courtesy of Tracy O per Creative Commons license)Employment has recovered in the U.S. since the Great Recession. But will wages catch up soon, too?FiveThirtyEight sees some hopeful signs in 2016: By some measures, earnings were already showing some growth at...
  • The Hottest Wearable Devices at CES 2016

    Critics of wearables have deemed them to be expensive toys. Some of the new wearable product offerings being announced may give fresh ammunition to that argument. Meanwhile, several companies continue to develop new types of health-related wearables, showing off their most recent technology at this year's CES.  Qmed StaffWearables are quickly becoming a staple technology at the annual Consumer Electronics Show in Las Vegas. This year's event includes a dedicated Wearables MarketplaceA Next...
  • Want to Win the MD&M West Innovation Prize?

    We are hosting a contest to acknowledge the most innovative new products, services, and technologies developed by MD&M West exhibitors.Chris Newmarker and Brian BuntzUBM is looking to identify the most innovative exhibitors at MD&M West, and give them the attention they deserve. The MD&M West Innovation Prize is a contest that will acknowledge the most innovative products, services, and technologies developed in recent years by exhibitors at the conference, held...
  • Smith & Nephew Snatches Up Surgical Robotics Firm for $275M

    The British orthopedic giant has completed its $275 million acquisition of robotic surgical device maker Blue Belt Technologies.Nancy CrottiBlue Belt’s (Plymouth, MN) Navio handheld, robotic-assisted technology guides the surgeon in creating a virtual surgical plan that removes the need for standard mechanical cutting guides and jigs.The handheld device helps the surgeon to prepare bone for implantation, according to the company’s website.Designed for partial-knee replacement surgery, Navio...
  • Congressman Wants Criminal Investigation of Morcellator Deaths

    Congressman Michael Fitzpatrick (R-PA) is seeking a criminal inquiry into deaths associated with the use of power morcellators, a controversial device that can unwittingly spread cancer in women who had uterine fibroids removed or hysterectomies performed.Brian BuntzRepresentative Mike Fitpatrick (R-PA, 8th District) is seeking answers from FDA, prominent hospitals, and device makers regarding morcellator deaths. In a letter to FDA’s Office of Criminal Investigations, Michael Fitzpatrick,...
  • Why Samsung Is Getting into the Wearables Chip Market

    The electronics giant has announced its plans to compete in the wearables space on two fronts: by continuing to compete head-to-head against other wearables makers while also providing chips to them. We reach out to an impartial industry veteran to get his take on the news.Brian BuntzJust before CES kicked off in Las Vegas, the company announced its Bio-Processor chip, which can monitor ECG levels, body fat, skin temperature, galvanic skin response, and heart rate. The Bio-Processor packs...
  • NBC Accuses CR Bard of Knowingly Selling Unsafe Device

    CR Bard’s G2 blood clot filter was meant to replace the troubled Recovery filter. NBC News now claims the device company continued to sell the G2 even after its officials were aware it could also fail.Both CR Bard's Recovery and G2 filters (the latter is pictured here) were placed inside the placed inside the inferior vena cava to catch blood clots. Qmed StaffCR Bard officials knew early on that their successor to the troubled Recovery blood clot filter was faulty, too, but they...
  • How a Glowing Bandage Could Tackle the Superbug Epidemic

    A new ‘smart’ bandage prototype could be used to alert healthcare professionals to the early signs of bacterial infections commonly found in wounds. The technology could improve wound treatments while also preventing the unnecessary use of antibiotics, and, by extension, the worsening superbug epidemic. Kristopher SturgisImage on left shows bandage before it contact bacterial toxins. The image on the right shows how it looks when activated by bacterial toxins.Researchers from Bath University in...
  • FDA Orders Vaginal Mesh Makers to File PMAs

    The U.S. FDA is tightening regulatory requirements for transvaginal meshes, which have turned into lawsuit magnets amid safety problems.Boston Scientific's mesh products include the Obtryx II. (Image courtesy of Boston Sci)Chris NewmarkerTransvaginal mesh devices used to treat pelvic organ prolapse will now be regulated in the U.S. as high-risk devices, with manufacturers required to submit a PMA submission, which requires data from a pivotal study.FDA on Monday issued two orders related...
  • 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 product that will be on display at their booth (Booth #2438) at MD&M West 2016.Custom compounder Teknor Apex (Pawtucket, RI) declares that it has assembled the broadest range of compounds in the medtech industry, which it will feature at MD...