The Latest Cardiac and Vascular News
MARSEILLE, France, Dec. 9, 2020 /PRNewswire/ — Volta Medical, a pioneering French-based HealthTech startup is pleased to announce that it has obtained FDA clearance for its revolutionary VX1 AI (artificial intelligence) software. This is the first FDA clearance for an AI based tool in interventional cardiac electrophysiology. VX1 is a machine and deep […]
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 […]
Required lab testing complete for Biotres a novel holter patch product REDWOOD CITY, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) — Biotricity Inc. (OTCQB:BTCY), a medical diagnostic and consumer healthcare technology company, announced today that it has completed required lab testing and is completing its 510(k) FDA filing for its latest potential product […]
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 […]
SimpleSENSE provides a continuous, simultaneous, and synchronous assessment of the heart, lungs, and upper vascular system without the need for an in-person doctor’s visit NEW YORK, Nov. 11, 2020 /PRNewswire/ — Nanowear www.nanowearinc.com, the leading connected-care and remote diagnostic platform, today announced it has received FDA Class II 510(k) clearance for a first-of-its-kind cloth-based […]
