The Latest Cardiac and Vascular News
– Large, Randomized Controlled ADVENT Trial Designed to Establish New Gold Standard for AF Ablation – MENLO PARK, Calif., Dec. 17, 2020 /PRNewswire/ – FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT […]
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF) Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of […]
LAKE OSWEGO, Ore., Dec. 16, 2020 /PRNewswire/ — BIOTRONIK today announced FDA clearance and availability of the Vital Data Sensor, which identifies body temperature increases potentially associated with fever, in the new BIOMONITOR IIIm injectable cardiac monitor (ICM), as shown in a published case report1. Physicians will now have access to daily reports on […]
MASON, Ohio–(BUSINESS WIRE)–Genetesis, Inc. announced today that its flagship product, CardioFlux®, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome. CardioFlux®, the most advanced commercially available magnetocardiograph (MCG), […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria™ biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will […]
– SoniVie Acquires New Intellectual Property and Other Assets from Cardiosonic Moving TIVUS into New Therapeutic Areas Beyond Pulmonary Hypertension – TEL AVIV, Israel, Dec. 09, 2020 (GLOBE NEWSWIRE) — SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound (TIVUS) System to treat a variety of hypertensive disorders, […]
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 […]
