Medical Device Industry News

  • St. Jude Medical May Not Have a Cybersecurity Problem After All

    Error alerts triggered by simulated attack are actually what show up when the St. Jude cardio device isn’t plugged in, researchers say. Nancy Crotti

  • Theranos Appealing Tough CMS Sanctions

    The company has halted tests at its California lab and says it has made improvements. Nancy Crotti

  • Getinge Board Gives CEO the Boot

    CEO Alex Myers had been in charge of the struggling Swedish medical device maker for less than 18 months. Chris Newmarker

  • Medtech, FDA Reach Tentative Agreement on Fees Legislation

    Industry hints at shorter review times, better process management. Nancy Crotti Three major medtech industry trade groups and FDA have hammered out a tentative agreement to update the Medical Device User Fee Act (MDUFA) with a continued emphasis on timely product reviews process improvements.

  • McDonald's Fitness Band Recall Numbers in Millions

    It turns out that the restaurant chain had to recall nearly 33 million fitness tracker Happy Meal toys in the U.S. and Canada because of a risk of skin irritation and burns.  Chris Newmarker

  • HeartWare Hit With Another LVAD Recall

    The company had complaints of contamination at the site where the driveline enters the controller. Nancy Crotti

  • Edwards Just Scored a Major TAVR Win

    Expanded FDA indication for the Sapien 3 marks the first time the agency has approved a TAVR for use in patients who only have intermediate risk of death or complications during surgery.  Chris Newmarker

  • Stryker Company Recalls Contaminated Cleansing Cloths

    The disposable cloths contain a potentially dangerous antibiotic-resistant microbe. Nancy Crotti

  • Phillips-Medisize Getting Acquired

    Electronics manufacturer Molex sees an opportunity to greatly expand its medical device presence by acquiring a major contract manufacturer in the space. Chris Newmarker Phillips-Medisize, a significant medical device contract manufacturer, is being snapped up by an electronics manufacturer for an undisclosed sum.

  • J&J Sued for Millions by Kentucky

    Kentucky Attorney General Andy Beshear claims the medical device giant failed to disclose the hazards related to its surgical transvaginal mesh products. Chris Newmarker