The Latest Cardiac and Vascular News
CARLSBAD, Calif.–(BUSINESS WIRE)–In an effort to battle Peripheral Artery Disease (PAD), the leading cause of limb amputations, the Food and Drug Administration (FDA) announced today that it has granted market clearance to Ra Medical Systems, makers of excimer lasers and […]
LAKE OSWEGO, Ore., May 8, 2017 /PRNewswire/ — BIOTRONIK today announced FDA approval of the company’s MultiPole Pacing (MPP) technology, providing physicians with additional treatment options for heart failure patients who have been non-responsive to cardiac resynchronization therapy (CRT).1 MPP will […]
MARLBOROUGH, Mass., May 9, 2017 /PRNewswire/ — 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. The approval includes new features […]
CARLSBAD, Calif.–(BUSINESS WIRE)–Acutus Medical®, a company committed to transforming the lives of millions of patients with complex arrhythmias, today announced the FDA clearance of the AcQGuide™ Steerable Sheath. The company will also feature several international presentations highlighting the AcQMap® High […]
Teleflex Receives FDA 510(k) Clearance for the Arrow® AC3 OptimusTM Intra-Aortic Balloon Pump (IABP) Advanced IABP performance with the ability to provide optimized therapy to the most challenging patient conditions, even patients with the most severe arrhythmias and heart rates […]
By Ken Dropkiewski The bioresorbable stent was approved for use by the FDA in July of 2016. The Absorb GT1 Bioresorbable Vascular Scaffold System, manufactured by Abbott, was all set to solve a litany of the problems inherent with conventional […]
REDWOOD CITY, Calif., April 12, 2017 (GLOBE NEWSWIRE) — Biotricity, Inc. (OTCQB:BTCY), a medical diagnostic and consumer healthcare technology company dedicated to delivering innovative, biometric remote monitoring solutions, has filed for a second and final 510(k) for the hardware portion of […]
Cardiovascular Systems, Inc. Receives Approval for the Diamondback 360® Coronary Orbital Atherectomy System (OAS) Micro Crown in the United States OAS Micro Crown Approved to Treat Severely Calcified Coronary Lesions Only Atherectomy Device Designed to Both Pilot Tight Lesions and […]
Press Release RESEARCH TRIANGLE PARK, N.C. — Humacyte, an innovator in biotechnology and regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted HUMACYL®, its investigational human acellular vessel (HAV), the Regenerative Medicine Advanced Therapy (RMAT) […]
VANCOUVER, British Columbia–(BUSINESS WIRE)–Aegis Medical Innovations Inc. (Aegis) today announced that it has received Investigational Device Exemption approval from the U.S. FDA to initiate a clinical trial in the U.S. for its medical device called the Sierra Ligation System (Sierra). […]
