The Latest Cardiac and Vascular News
Comaneci™ temporarily expands blood vessels–recognized as novel device for life-threatening disease YOKNEAM, Israel & MIAMI–(BUSINESS WIRE)–Rapid Medical, a leading developer of advanced neurovascular devices, today announced FDA breakthrough designation for its Comaneci™ embolization assist device to facilitate the treatment of cerebral vasospasm following hemorrhagic […]
WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke. Asundexian is […]
Malmö, Sweden, February 9, 2022 Acarix submits breakthrough designation request with FDA for heart failure diagnosis Acarix expands its portfolio and submits a breakthrough designation request for its innovative technology for heart failure diagnosis with the Food and Drug Administration (FDA) in USA. Heart failure […]
Company’s reSept™ ASD Occluder Aims to Evolve Septal Closure with its Novel Metal-Free Frame Design BAAR, Switzerland and SANTA CLARA, Calif., Feb. 8, 2022 /PRNewswire/ — atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects […]
NASHVILLE, Tenn., Feb. 8, 2022 /PRNewswire/ — IVX Health, a national provider of infusion and injection therapy for patients with complex chronic conditions, announced today the expansion of its injection formulary with the addition of Leqvio® (inclisiran), a new FDA-approved therapy by Novartis Pharmaceuticals Corporation indicated for the […]
BOSTON, Feb. 8, 2022 /PRNewswire/ — CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to […]
PDUFA Target Action Date Set for November 30, 2022 FDA is Currently Not Planning to Hold an Advisory Committee Meeting to Discuss the Application SOUTH SAN FRANCISCO, Calif., Feb. 04, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that […]
SUNNYVALE, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy […]
AliveCor launches KardiaMobile Card, the only personal ECG slim enough to fit in a wallet for instant feedback on heart health anytime, anywhere MOUNTAIN VIEW, Calif., Feb. 1, 2022 /PRNewswire/ — AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced […]
LAS VEGAS–(BUSINESS WIRE)–AIROS Medical, Inc., a designer, manufacturer, and distributor of compression therapy devices, and Fist Assist Devices, LLC (Fist Assist), an innovative medical device company, today announced the launch of an e-commerce website, www.fistassistusa.com, for the sale of the Fist Assist […]
