The Latest Cardiac and Vascular News
EchoGo® Heart Failure revolutionizes the detection of HFpEF – the biggest unmet need in cardiovascular medicine.1 OXFORD, England, Dec. 6, 2022 /PRNewswire/ — Ultromics’ EchoGo® Heart Failure, an AI solution for echocardiography with the potential to revolutionize the diagnosis of heart failure with […]
Approval marks second clinical trial approved by FDA this year for Company’s NK1R+ MSC platform Allogeneic CardiALLO therapy for heart failure to complement autologous cell therapy currently enrolling in Phase III CardiAMP Heart Failure clinical trial SUNNYVALE, Calif.–(BUSINESS WIRE)–BioCardia, Inc. [Nasdaq: BCDA], […]
New AI device expands Diagnostics as a Service platform capabilities. NEW YORK , Dec. 5, 2022 /PRNewswire/ — Imagen Technologies, Inc. announced the U.S. Food and Drug Administration’s 510(k) clearance of the computer-assisted detection (CADe) device Aorta-CAD. This new, FDA cleared device is designed […]
U.S. Clinical Trial Commencement Anticipated in 1Q2023 BRISBANE, Australia & EAGAN, Minn.–(BUSINESS WIRE)–Anteris Technologies Ltd (ASX: AVR), a structural heart company developing DurAVR™, the world’s only balloon-expandable, 3D single-piece aortic valve shaped to mimic the native human valve, today announced […]
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces that Impella RP Flex with SmartAssist has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA), the FDA’s highest level of approval, as safe and effective to treat acute right heart failure for up […]
GENEVA, Oct. 25, 2022 /PRNewswire/ — Following our communication last week “MedAlliance to be acquired by Cordis”, MedAlliance is pleased to make the following announcement: SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to initiate its coronary pivotal […]
WASHINGTON–(BUSINESS WIRE)–CorVista Health, Inc, a digital health company dedicated to improving cardiovascular disease diagnosis, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CorVista System as a first non-invasive point of care diagnostic […]
U.S. FDA has assigned a target action date of June 16, 2023 Application based on results from the Phase 3 VALOR-HCM study PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted […]
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces the U.S. Food and Drug Administration (FDA) has accepted and closed the post-approval study reports related to the pre-market approvals (PMA) for Impella heart pumps. The FDA’s action is another affirmation that Impella heart pumps are […]
HeartFlow is the first and only company to provide non-invasive anatomy, physiology, and plaque information based on coronary computed tomography angiography (CCTA) MOUNTAIN VIEW, Calif., Oct. 18, 2022 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, has […]
