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  • Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

    Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017. Globus Medical, which describes itself as a musculoskeletal implant manufacturer, acquired the robotics developer Excelsius Surgical and its robotic guidance device Excelsius GPSTM t ...
  • House Passes Bill Relaxing Reporting Requirements

    The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017.  This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA.  Previously, companies had to submit a report within 30 days of  a problem.  Under the current version of the Reauthorization Act, companies will be able to submit reports once every three months inst ...
  • FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

    The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k).  The Notice indicates that anyone with pending 510(k) submissions for devices that are now exempt "should withdraw their submissions." According to the Notice, the exemptions from the 510(k) requiremen ...
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.