The Latest Cardiac and Vascular News
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 is manufactured by Abiomed (NASDAQ: ABMD). COVID-19 causes widespread inflammation which can […]
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 of symptomatic, obstructive hypertrophic cardiomyopathy (HCM). The FDA’s Breakthrough Therapy […]
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 medical AI technology, has received FDA 510(k) clearance for an […]
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 for the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. Experience […]
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 valved conduit (AVC), the first ready-to-implant solution for bio-Bentall procedures, […]
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, Phonocardiograph and Electrocardiograph combined into one device. HD Steth utilizes […]
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 CO-Pilot is a handheld device with wireless capabilities that helps […]
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 approval for its LINQ II™ insertable cardiac monitor (ICM) with […]
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 bring new benefits to patients with heart rhythm disorders, including […]
Dr. Brajesh Lal of the University of Maryland Presents Study Data at the Society for Vascular Surgery Conference July 01, 2020 08:30 AM Eastern Daylight Time BOSTON–(BUSINESS WIRE)–Elucid Bio, maker of the FDA-cleared and CE-marked vascuCAP® software, announced today that its novel artificial intelligence (AI) technology demonstrated an over 70 […]
