Tag: FDA

Surmodics Receives FDA 510(k) Clearance for Sublime™ Radial Access 0.014 RX PTA Dilatation Catheter

Device designed to treat below-the-knee vessels from the radial arteries with industry’s longest (250 cm) working length EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it […]

FDA Issues Emergency Use Authorization for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients

DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis. Impella […]

MyoKardia Announces Receipt of Breakthrough Therapy Designation from FDA for Mavacamten for the Treatment of Symptomatic, Obstructive Hypertrophic Cardiomyopathy

BRISBANE, Calif., July 23, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to mavacamten, a novel, oral, allosteric modulator of cardiac myosin, for the treatment […]

Boston Scientific Receives FDA Approval for Next-Generation WATCHMAN FLX™ Left Atrial Appendage Closure Device

New stroke risk reduction technology designed to advance procedural performance and safety, treat wider range of patients with non-valvular atrial fibrillation MARLBOROUGH, Mass., July 21, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval […]

Edwards’ KONECT RESILIA Aortic Valved Conduit Receives FDA Approval For Complex Aortic Valve Surgeries

IRVINE, Calif., July 15, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it received approval from the U.S. Food and Drug Administration (FDA) for the KONECT RESILIA aortic […]

Nonin Medical Announces FDA Clearance of the CO-Pilot™ Wireless Handheld Multi-Parameter System

Device and sensors help EMS, fire departments and military track five patient parameters MINNEAPOLIS, July 8, 2020 /PRNewswire/ — Nonin Medical, Inc. today announced the CO-Pilot™ Wireless Handheld Multi-Parameter System (H500) received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The […]

Medtronic Gains FDA Clearance, CE Mark for LINQ II™ Insertable Cardiac Monitor (ICM)

Next Generation ICM Offers Remote Programming with Improved Longevity and Enhanced Accuracy DUBLIN, July 07, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) clearance and CE (Conformité Européenne) Mark […]

Abbott Receives FDA Approval for New Heart Rhythm Devices Featuring Bluetooth Connectivity and Continuous Remote Monitoring

ABBOTT PARK, Ill., July 6, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s next-generation Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The devices […]