Regulatory News

  1. Medtronic’s Resolute Onyx Drug-Eluting Stent Approved By FDA
    5/1/2017

    Medtronic plc recently announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Resolute Onyx Drug-Eluting Stent (DES). The Resolute Onyx DES builds on the proven clinical performance and superior deliverability of the Resolute Integrity DES to further strengthen the gold standard safety and efficacy of DES technology.

  2. Galatea Surgical’s 3D Surgical Scaffold For Reconstructive Surgery Cleared By FDA
    4/27/2017

    Galatea Surgical, a wholly owned subsidiary of Tepha Inc., announced today the FDA 510k clearance of its GalaFORM™ 3D Surgical Scaffold ("GalaFORM 3D") for use in plastic and reconstructive surgery. Based on Tepha's proprietary P4HB™ bioresorbable polymer technology, GalaFORM 3D is the only 3-dimensionally contoured, surgical scaffold with a reinforcing rim, designed to uplift the body's natural shape, provide easier placement and reduce procedure time.

  3. Contego Medical’s Peripheral Balloon Angioplasty System Earns CE Mark Approval
    4/27/2017

    Contego Medical, LLC announced today that it has received CE Marking of its Vanguard IEP™ Peripheral Balloon Angioplasty System with Integrated Embolic Protection.

  4. Intuitive Surgical’s da Vinci X System Gains CE Mark Approval
    4/26/2017

    Intuitive Surgical, a global technology leader in robotic-assisted, minimally invasive surgery, announced today that its new da Vinci X Surgical System received CE Mark approval in Europe.

  5. joimax’s Spinal Surgery Device Cleared By FDA
    4/26/2017

    joimax, the German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery, recently announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endovapor 2 Multi Radio Frequency System.

  6. Allergan Gets FDA OK To Market Neurostimulator That Temporarily Increases Tear Production
    4/25/2017

    Allergan plc, (NYSE: AGN) today announced that it has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) for TrueTear™ Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.Allergan plc, (NYSE: AGN) today announced that it has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) for TrueTear™ Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.

  7. FDA Clears First Cooled RF Treatment For OA Knee Pain
    4/20/2017

    American Society of Interventional Pain Physicians Annual Meeting, Booth #407 -- Halyard Health (NYSE: HYH), a medical technology company focused on eliminating pain, speeding recovery and preventing infection, today announced the U.S. Food and Drug Administration (FDA) has cleared for marketing its COOLIEF* Cooled Radiofrequency (Cooled RF) thermal treatment for the relief of chronic moderate to severe knee pain caused by osteoarthritis (OA).

  8. Edwards Lifesciences' Hemodynamic Monitoring Platform Cleared By FDA
    4/19/2017

    Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, has received FDA clearance for its HemoSphere advanced monitoring platform.

  9. J&J’s Ethicon Gains FDA Clearance For Echelon Circular Powered Stapler
    4/19/2017

    The circular anastomosis is one of the most critical steps in cancer surgery and has a high risk for complications. Complications can include leaks and bleeding which can require reoperation

  10. Monitored Therapeutics’ GoSpiro Is First FDA-Cleared Connected, Full Home Use Spirometer
    4/18/2017

    Monitored Therapeutics, Inc. (MTI), an emerging best-in-class remote patient management company, has received FDA 510(k) clearance for its GoSpiro® Home Spirometer.