The Latest Cardiac and Vascular News
WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its Serranator® PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions. The Serranator device is the first and only angioplasty balloon FDA […]
PORTLAND, Ore., April 23, 2020 /PRNewswire/ — VisCardia Inc., a privately held medical device developer, announced today it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its implantable VisONE® system designed for the treatment of moderate to […]
Endospan is Granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the NEXUS™ Aortic Arch Stent Graft System. HERZLIA, Israel–(BUSINESS WIRE)–Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease was recently granted Breakthrough Device […]
Swedish Heart-Lung Home Monitor Expands Indications for use in COVID-19 Respiratory Diagnostic Exams IRVINE, Calif., April 15, 2020 /PRNewswire/ — Coala Life, a leading Swedish digital health company has, as supported by FDA’s Emergency Guidance, expanded the indication for use enabling physicians to remotely, […]
MONMOUTH JUNCTION, N.J., April 13, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the United States Food and Drug Administration (FDA) has granted Emergency […]
Sotatercept granted first FDA Breakthrough Therapy designation in pulmonary arterial hypertension since the Agency established the designation in 2012 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics […]
RESEARCH TRIANGLE PARK, N.C., April 08, 2020 (GLOBE NEWSWIRE) — Liquidia Technologies, Inc. (Nasdaq: LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products utilizing its proprietary PRINT® technology, today announced that the U.S. Food and Drug […]
Designed solely for antegrade approach, NovaCross™ is positioned to tap into the $500M CTO market, a market with only few players PARDES HANA, Israel, April 7, 2020 /PRNewswire/ — Nitiloop Ltd. to announce that it has received a 510(k) clearance from the U.S. Food […]
SOUTH JORDAN, Utah, April 06, 2020 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today […]
First and Only Treatment to Reduce Heart Muscle Damage Following Angioplasty and Stenting CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei Group company that manufactures medical devices and related software solutions, announced today it has received U.S. Food and Drug Administration […]
