DUBLIN, Aug. 23, 2023 /PRNewswire/ — Today, Medtronic announced the outcome of the U.S. Food & Drug Administration (FDA) Circulatory System Devices Panel (CSDP) meeting to review data presented in support of the Medtronic Symplicity Spyral™ Renal Denervation (RDN) System. The panel Committee voted unanimously (13-0) on safety and in favor (7-6) […]
Coronary/Structural Heart
Windtree Announces Issuance of Composition of Matter Patent for Dual Mechanism SERCA2a Activators by the US Patent and Trademark Office
WARRINGTON, Pa., Aug. 23, 2023 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today reported that the United States Patent and Trademark Office (USPTO) has issued US Patent No. 11,730,746 covering the Company’s dual mechanism […]
Aquedeon Medical, Inc. Receives FDA IDE Approval for the Duett Vascular Graft System
SUNNYVALE, Calif., Aug. 23, 2023 /PRNewswire/ — Aquedeon Medical, Inc., a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the […]
Recor Medical and Otsuka Medical Devices Announce Positive Vote from U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System for the Treatment of Hypertension
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 […]
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 […]
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