Regulatory News

  1. Edwards' INSPIRIS RESILIA Valve Receives FDA Approval
    7/5/2017

    Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, recently announced it received U.S. Food and Drug Administration (FDA) approval for its INSPIRIS RESILIA aortic valve, the first in a new class of resilient heart valves.

  2. Varian’s Image-Guided Radiotherapy Systems Earns FDA Clearance
    6/29/2017

    Varian Medical Systems (NYSE: VAR) has received FDA 510(k) clearance for its Halcyon™ system, its new device for cancer treatment. Halcyon simplifies and enhances virtually every aspect of image-guided volumetric intensity modulated radiotherapy (IMRT).

  3. FDA Clears Philips’ Ninth Version Of IntelliSpace Portal Image Analytics Platform
    6/27/2017

    Royal Philips, a global leader in health technology, recently announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market IntelliSpace Portal 9.0 and a range of innovative applications for Radiology in the U.S.

  4. FDA Grants Merit Medical’s Embosphere Microspheres de novo Classification For Prostatic Artery Embolization)
    6/22/2017

    Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy, today announced that it has received 513(f)(2) (de novo) classification from the FDA to expand indication for Merit’s Embosphere® Microspheres.

     

  5. FDA Clears First RF Ablation Treatment For Osteoarthritis Knee Pain
    6/20/2017

    The U.S. Food and Drug Administration (FDA) has approved the first and only radio frequency (RF) treatment to be cleared specifically to alleviate chronic knee pain due to osteoarthritis.

  6. Cook Medical’s Esophogeal Repair Device For Infants Cleared By FDA
    5/12/2017

    The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia.

  7. Medtronic’s Quadripolar CRT-Ps Gain FDA Approval
    5/10/2017

    Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for a portfolio of quadripolar cardiac resynchronization therapy-pacemakers (CRT-Ps) that improve therapy delivery for patients with heart failure.

  8. Boston Scientific’s Resonate ICDs, CRT-Ds Gain FDA Approval
    5/9/2017

    Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the Resonate™ family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems.

  9. Abbott’s Sensor-Enabled Ablation Catheter Gains CE Mark Approval
    5/9/2017

    Abbott (NYSE: ABT) today announced CE Mark of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™, developed to make it easier for physicians to more effectively treat atrial fibrillation (AF), a condition in which the upper chambers of the heart beat too fast.

  10. Abbott Wins CE Mark For First Smartphone-Compatible Insertable Cardiac Monitor
    5/8/2017

    Abbott (NYSE: ABT) today announced CE Mark and first use of the new Confirm Rx™ Insertable Cardiac Monitor (ICM), the world's first smartphone compatible ICM that will help physicians identify difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), to help guide therapy.