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  • FDA to Create New Digital Health Unit

    The FDA has announced that it will create a new unit responsible for overseeing digital health products.  According to Bakul Patel, the Associate Center Director for Digital Health at FDA, the agency is working to define "what clinical validation looks like for software," and will consider creating new premarket approval or clearance procedures for digital health products. As Patel stated in a ...
  • Medtronic’s Recent Interactions with the FDA

    It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency.  Below is a brief summary of some recent of Medtronic's recent interactions with the  FDA. First, in early April, the FDA announced that Medtronic was notifying customers of a voluntary field corrective action fo ...
  • FDA Approves Bayer’s myBETAapp™

    On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer's myBETAapp™ and BETACONNECT Navigator™.  The myBETAapp joins the growing field of medical mobile applications, which the FDA predicts will reach 1.7 billion smartphone or tablet users by 2018. According to Bayer, the myBETAapp connects their BETACONNECT autoinjector (for delivering BE ...
Conferences
  • Sep

    11

    Vascular InterVentional Advances (VIVA)

    Wynn Hotel

    September 11 - 14, 2017

    Las Vegas, NV

    VIVA is the premier global, multidisciplinary course for vascular intervention and medicine. For the past 11 years, VIVA has defined excellence in professional education by offering attendees an innovative, provocative, and balanced educational experience, enhanced by the use of technology and electronic interaction between participants and faculty experts.