The Latest Cardiac and Vascular News
FDA Clears Potential Hurdle for Many Heart Failure Patients MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval […]
SCHAFFHAUSEN, Switzerland, Jan. 19, 2021 /PRNewswire/ — Occlutech, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction. Heart failure (HF) […]
RIDGEFIELD, Conn. and INDIANAPOLIS, Jan. 11, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalization for heart failure and to slow kidney function decline in adults with […]
EchoGo Pro is an AI service for automated identification of coronary artery disease – FDA gives 510(K) clearance for EchoGo Pro, expanding the use of Ultromics’ EchoGo service to support clinicians diagnosing coronary artery disease – Every year in the U.S. over 800,000 people die from heart disease – accounting […]
Neuronaute® EEG System and IceCap® bring Comprehensive Remote Electroencephalography Monitoring Services to People Living with Neurological Disorders. PARIS and ATLANTA, Jan. 5, 2021 /PRNewswire/ — BioSerenity, Inc., a leading global provider of remote diagnostic solutions in the areas of Neurology, Cardiology and Sleep Disorders announced today it received U.S. Food and Drug Administration (FDA) 510(k) […]
BEDMINSTER, N.J., Jan. 04, 2021 (GLOBE NEWSWIRE) — Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced the U.S. Food and Drug Administration (FDA) has conditionally accepted LYPDISO™ as the […]
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 […]
CE marking allows the company to market its total artificial heart in the EU as a bridge to transplant Virtual press conference scheduled on January 6, 2021 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an […]
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 […]
