The Latest Cardiac and Vascular News
Expansion includes adolescent patients, as young as 12 years of age, who can benefit from cryo nerve block therapy during surgical procedures involving the chest wall. MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced that […]
DRIVEWIRE™ provides efficient access in difficult neuro and peripheral vascular procedures YOKNEAM, Israel & MIAMI–(BUSINESS WIRE)–Rapid Medical, a company focused on the development of the first class of responsive, adjustable neurovascular devices, announces the FDA clearance of DRIVEWIRE, a novel guidewire with a steerable distal tip that handles complex anatomical […]
TricValve® made in Europe VIENNA, Dec. 22, 2020 /PRNewswire/ — P+F Products + Features GmbH has been granted designation as a Breakthrough Device for the company’s lead product, the TricValve® Transcatheter Bicval Valves System by the U.S. Food & Drug Administration on December 15th 2020. The TricValve® is a system of two self-expanding biological valves for […]
– 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 […]
