Medical Device Industry News

  • Hoya Spending $476 Million on Lens Maker

    Performance Optics LLC has a specialty in eyeglass lenses. Chris Newmarker

  • Theranos Sued by Major Investor

    The beleaguered Silicon Valley company lied to win over investors, according to a major funder. Theranos denies the accusation.  Qmed Staff

  • Alphatec Laying Off Dozens of Workers

    The spine device company’s chief financial officer has also resigned. Chris Newmarker Alphatec recently announced that it will cut its workforce by about a fifth amid a $20 million expense cutting plan. The company had 430 employees as of December 31, 2015, according to its most recent annual report. So the jobs cuts could affect more than 80 workers.

  • EpiPen Maker Settles With DOJ for $465 Million

    The company was accused of paying state Medicaid programs a generic rebate for brand-name product. Nancy Crotti

  • Vascular Solutions Hit With Another Class I Recall

    This time, the recall involves nearly 16,000 catheters.  Maureen Kingsley A potential defect in some of Vascular Solutions’s dual-access catheters may pose a risk of embolism in patients, the Maple Grove, MN–based company has announced.  Vascular Solutions initiated a recall of the Twin-Pass dual-access catheters on September 16; the company says FDA has designated the recall as Class I level.

  • St. Jude Wins FDA Approval for Next-Gen Brain Stimulator

    The Infinity deep brain stimulation system boasts a directional lead and a software platform that connects to Apple devices. Chris Newmarker

  • Stryker's Trevo Just Got a Major Boost

    The decision by FDA to expand the Trevo’s indication could potentially help hundreds of thousands of people experiencing strokes each year. Chris Newmarker

  • Edwards Lands CE Mark for Hypotension Detector

    The software automatically updates advanced parameters every 20 seconds to better reflect rapid physical changes in moderate to high-risk surgical or critical care patients. Nancy Crotti

  • Bioabsorbable Heart Valves Tried Out in Children

    The Swiss-Dutch medical device company Xeltis has launched a multi-centered feasibility trial. Chris Newmarker

  • Ultrasonic Surgical Device Maker Has Potential FCPA Problems

    Misonix (Farmingdale, NY) says it voluntarily alerted federal authorities about problems at a Chinese distributor. Chris Newmarker An independent Chinese distributor may have been engaging in business practices that violated the U.S. Foreign Corrupt Practices Act, ultrasonic surgical device maker Misonix has disclosed in an SEC filing. Misonix officials voluntarily alerted the SEC and U.S. Justice Department about the problems.