Medical Device Industry News

  • 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.

  • Global Medical Disposables Market to Reach $273 Billion

    Expect 6.2% annual growth a year, according to a new report. Qmed Staff

  • Did EpiPen Maker Fudge Profit Numbers?

    Mylan’s profits for the drug delivery device were 60% higher than what the company’s CEO told Congress, according to The Wall Street Journal. Nancy Crotti

  • Boston Sci Making $210 Million Acquisition

    Buying EndoChoice Holdings will allow Boston Sci to expand its successful endoscopy business. Chris Newmarker

  • Medtronic Scores a Big Legal Win

    A federal judge in Ohio has dismissed hundreds of Infuse bone graft lawsuits, which claimed off-label use of the device.   Nancy Crotti