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 […]
Tag: FDA
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 […]
Caption Health Receives FDA 510(k) Clearance for Innovation in Point-of-Care Ejection Fraction Evaluation
Latest AI ultrasound tool makes it even easier to automatically assess ejection fraction, a key indicator of cardiac function, at the bedside–including on the front lines of the COVID-19 pandemic BRISBANE, Calif., July 23, 2020 /PRNewswire/ — Caption Health, a leader in […]
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 […]
HD Medical Awarded FDA Clearance For HD Steth
Intelligent Stethoscope with Integrated ECG delivers Instant Cardiac Insights SANTA CLARA, Calif.–(BUSINESS WIRE)–HD Medical, Inc. of Silicon Valley today announces that its flagship product, HD Steth, has received FDA clearance for all three product classification codes of DQD, DQC and DPS for Electronic Stethoscope, […]
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 […]