The Latest Cardiac and Vascular News
Novel radial artery occlusion device removes the guesswork from achieving Patent Hemostasis HOLLAND, Mich., Dec. 9, 2020 /PRNewswire/ — Genesis Innovation Group’s cultivate(MD) Capital Fund II LP, a fund focused on investments into early stage healthcare companies with innovative technologies, announces that one of their portfolio companies, Wheaton, IL-based Medical Ingenuities, a medical device company […]
Press release (MAR) Malmö, Sweden, November 26, 2020 FDA identifies exclusive code for the CADScor® After yesterday’s announcement and further analysis of the FDA approval, Acarix AB today announce that the company’s marketing approval of the CADScor®System in the US was granted under a new generic type of code and […]
Press release (MAR) Malmö, Sweden November 25, 2020 Acarix receives US market approval for the CADScor® System Acarix AB (publ) today announced that the US Food and Drug Administration (FDA) has approved the company’s De Novo application for marketing approval of the CADScor®System in the US. “This is a major achievement […]
AliveCor Paving the Way For A New Generation of AI-Powered Remote Cardiology MOUNTAIN VIEW, Calif., Nov. 23, 2020 /PRNewswire/ — AliveCor, the leader in AI-based personal ECG technology and provider of enterprise cardiology solutions, today announced that the US FDA had given clearance to the company’s next generation of interpretive ECG algorithms. “Kardia […]
Lightning 12 and Separator 12 Now Indicated for Treatment of PE ALAMEDA, Calif.–(BUSINESS WIRE)–Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo® Aspiration System, Lightning™ 12. As part of […]
Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment TEWKSBURY, Mass., Nov. 17, 2020 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), today announced completion of randomization in its REDUCE LAP-HF II global, pivotal trial. The trial […]
IDE Approval Clears Path to U.S. Clinical Trial Launch for Vascular Sealant PARIS–(BUSINESS WIRE)–TISSIUM, a privately-owned medtech company developing biomorphic programmable polymers for tissue reconstruction, announced today it has received approval from the U.S. Food and Drug Administration for its Investigational Device Exemption application for its vascular sealant. The approval […]
Company provides physicians with first portfolio comprised of drug-eluting stent and drug-coated balloon for the treatment of patients with peripheral artery disease MARLBOROUGH, Mass., Nov. 2, 2020 /PRNewswire/ — Boston Scientific (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval of the Ranger™ Drug-Coated Balloon, developed for the treatment […]
This 7th FDA clearance further solidifies DiA’s leadership in the ultrasound AI space. BE’ER SHEVA, Israel, Oct. 29, 2020 /PRNewswire/ — DiA Imaging Analysis announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the commercial use of LVivo Seamless for automatic view selection. LVivo Seamless algorithms automatically […]
VANCOUVER and MINNEAPOLIS, Oct. 28, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that the United States Food and Drug Administration’s (FDA’s) Circulatory System Devices Advisory Panel voted 14 to 4 “in favor” that the Neovasc Reducer™ is safe when used as intended, and voted 1 to […]
