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 […]
Tag: FDA
Medical Ingenuities Receives FDA 510(k) Clearance for PH Band
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 […]
FDA identifies exclusive code for the CADScor®
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 […]
Acarix receives US market approval for the CADScor® System
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 […]
FDA Clears First of its Kind Algorithm Suite for Personal ECG
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 […]
Penumbra’s Newest Generation of Indigo Aspiration System Receives FDA Clearance for Pulmonary Embolism
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 […]
Corvia Medical Completes Randomization In REDUCE LAP-HF II Pivotal Trial And Gains FDA Authorization To Provide Continued Access For The Corvia Atrial Shunt
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 […]
TISSIUM Receives FDA Investigational Device Exemption for Vascular Sealant
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 […]
Boston Scientific Receives FDA Approval for the Ranger™ Drug-Coated Balloon
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) […]
DiA Granted FDA Clearance for its Cardiac Ultrasound AI Auto Views Selection
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 […]