Regulatory News

81. FDA Approves Medtronic's CoreValve Evolut TAVR For Expanded Indication 7/10/2017

    Medtronic plc recently announced the expanded U.S. Food and Drug Administration (FDA) approval of the self-expanding CoreValve Evolut transcatheter aortic valve replacement (TAVR) platform to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.

82. Cerus Endovascular's Neurovascular Systems Earns CE Mark Approval 7/6/2017

    Cerus Endovascular Ltd. today announced that it has received CE Mark approval for the commercial sale of its Contour Neurovascular System™ for the treatment of intra-cranial aneurysms (IAs) across the European Union (EU).

83. 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.

84. 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).

85. 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.

86. 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.

     

87. 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.

88. 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.

89. 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.

90. 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.