PALO ALTO, Calif.–(BUSINESS WIRE)– Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announce the U.S. Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise™ Ultrasound Renal Denervation (RDN) system, indicated to […]
Coronary/Structural Heart
Magenta Medical Completes Enrollment to Early Feasibility Study for World’s Smallest Heart Pump
KADIMA, Israel, Aug. 22, 2023 /PRNewswire/ — Magenta Medical, developer of the world’s smallest heart pump, announced today the completion of enrollment to its FDA-approved Early Feasibility Study with the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) for the high-risk percutaneous coronary intervention (HR-PCI) indication. All 15 study patients were enrolled and successfully treated […]
BaroPace, Inc. Announced First Patient Enrolled in Non-Pharmacologic Hypertension and Heart Failure Treatment Trial
SAMMAMISH, Wash.–(BUSINESS WIRE)– BaroPace Inc., a medical device company focused on the development of PressurePace™, a real-time physiologic control software and hardware to regulate cardiac pacemakers to treat resistant hypertension and heart failure with preserved ejection fraction (HFpEF), today announced that the first patient has been enrolled in the Company’s First-in-Human […]
Bristol Myers Squibb to Showcase Data Across its Innovative Cardiovascular Portfolio at the European Society of Cardiology Congress 2023
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced the presentation of research reinforcing the strength of its robust cardiovascular portfolio at the European Society of Cardiology (ESC) Congress, taking place in-person and virtually August 25-28, 2023. Data from clinical studies will be featured, including presentations of CAMZYOS® (mavacamten) cumulative analysis up to […]
Imbria Pharmaceuticals Completes Enrollment in the Phase 2 IMPROVE-ISCHEMIA Clinical Trial of Ninerafaxstat in Patients with Stable Angina
BOSTON, Aug. 16, 2023 (GLOBE NEWSWIRE) — Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company dedicated to developing innovative therapies designed to improve patient symptoms and function by enhancing cellular energetics, today announced that it has completed enrollment in the IMPROVE-ISCHEMIA Phase 2 placebo-controlled clinical trial of the investigational therapy, […]
Viz.ai Receives First De Novo Approval by the FDA for Hypertrophic Cardiomyopathy AI Algorithm
SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received a De Novo approval by the U.S. Food and Drug Administration (FDA) for its Viz HCM module, a hypertrophic cardiomyopathy (HCM) artificial intelligence (AI) detection algorithm, creating a new regulatory category for […]
CytoSorbents Completes U.S. and Canadian STAR-T Pivotal Trial
PRINCETON, N.J., Aug. 14, 2023 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has completed the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial, following the last scheduled patient follow-up. The […]
DurAVR™ THV Demonstrates Exceptional Results in Second Valve-in-Valve Case
BRISBANE, Australia & MINNEAPOLIS–(BUSINESS WIRE)– Anteris Technologies Ltd (Anteris or the Company) (ASX: AVR, OTC: ANTTY) reported today that DurAVR™ THV, a new class of biomimetic heart valve and the world’s only balloon-expandable, single-piece transcatheter aortic valve was implanted in a second successful Valve-in-Valve (ViV) procedure as part of Health Canada’s Special […]
Anteris Technologies Commences US Early Feasibility Study
BRISBANE, Australia & MINNEAPOLIS–(BUSINESS WIRE)–Anteris Technologies Ltd, (Anteris or the Company) (ASX: AVR, OTC: ANTTY) reported today that DurAVR™ Transcatheter Heart Valve (THV), a new class of biomimetic valve and the world’s only biomimetic, single-piece transcatheter aortic valve, was used to successfully to treat patients as part of the DurAVR™ […]
Novo Nordisk A/S: Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in the SELECT trial
Bagsværd, Denmark, 8 August 2023 – Novo Nordisk today announced the headline results from the SELECT cardiovascular outcomes trial. The double-blinded trial compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to standard of care for prevention of major adverse cardiovascular events (MACEs) over a period of up to five years. […]



