The Latest Cardiac and Vascular News
Neuronaute® EEG System and IceCap® bring Comprehensive Remote Electroencephalography Monitoring Services to People Living with Neurological Disorders. PARIS and ATLANTA, Jan. 5, 2021 /PRNewswire/ — BioSerenity, Inc., a leading global provider of remote diagnostic solutions in the areas of Neurology, Cardiology and Sleep Disorders announced today it received U.S. Food and Drug Administration (FDA) 510(k) […]
BEDMINSTER, N.J., Jan. 04, 2021 (GLOBE NEWSWIRE) — Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced the U.S. Food and Drug Administration (FDA) has conditionally accepted LYPDISO™ as the […]
Expansion includes adolescent patients, as young as 12 years of age, who can benefit from cryo nerve block therapy during surgical procedures involving the chest wall. MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced that […]
CE marking allows the company to market its total artificial heart in the EU as a bridge to transplant Virtual press conference scheduled on January 6, 2021 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an […]
DRIVEWIRE™ provides efficient access in difficult neuro and peripheral vascular procedures YOKNEAM, Israel & MIAMI–(BUSINESS WIRE)–Rapid Medical, a company focused on the development of the first class of responsive, adjustable neurovascular devices, announces the FDA clearance of DRIVEWIRE, a novel guidewire with a steerable distal tip that handles complex anatomical […]
TricValve® made in Europe VIENNA, Dec. 22, 2020 /PRNewswire/ — P+F Products + Features GmbH has been granted designation as a Breakthrough Device for the company’s lead product, the TricValve® Transcatheter Bicval Valves System by the U.S. Food & Drug Administration on December 15th 2020. The TricValve® is a system of two self-expanding biological valves for […]
New Software Version for Vantage Orian 1.5T Also Offers Solution to Help Clinicians Image and Quantify Fatty Liver Disease TUSTIN, Calif.–(BUSINESS WIRE)–Hospitals and institutions are continually looking for ways to improve diagnostic imaging throughput, especially in today’s environment where disinfection of systems and rooms in between patients is crucial. Now, […]
– Abbott’s HeartMate 3™ heart pump approved for use for pediatric patients battling advanced heart failure – This life-saving technology provides new treatment option for underserved population ABBOTT PARK, Ill., Dec. 17, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved updated labeling for the […]
SCHAFFHAUSEN, Switzerland, Dec. 18, 2020 /PRNewswire/ — Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH). PAH affects hundreds of thousands in the U.S. and globally and […]
TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed […]
