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], a developer of cellular and cell-derived therapeutics for the treatment […]
Tag: FDA
Imagen Technologies Announces FDA Clearance of Aorta-CAD
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 to assist physicians at detecting findings on chest X-rays that […]
Anteris Technologies Receives FDA Clearance to Initiate Early Feasibility Study for its Novel TAVR Product, DurAVR™
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 the U.S. Food and Drug Administration (FDA) has conditionally approved […]
Impella RP Flex with SmartAssist Receives FDA Approval to Treat Right Heart Failure
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 to 14 days. Impella RP Flex is implanted via the […]
MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval
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 clinical trial. This is the first sustained limus release coronary […]
CorVista Health Receives Breakthrough Device Designation for The CorVista® System
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 solution for patients with suspected pulmonary hypertension. The FDA’s Breakthrough […]
U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for CAMZYOS® (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy to Reduce the Need for Septal Reduction Therapy
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 its supplemental new drug application (sNDA) for CAMZYOS® (mavacamten) for an […]
Abiomed Successfully Completes All Impella Post-Approval Studies for High-Risk PCI, Cardiogenic Shock, Post-Cardiotomy Cardiogenic Shock and Right Heart Failure
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 safe and effective for cardiogenic shock, high-risk PCI, post-cardiotomy cardiogenic […]
HeartFlow Receives FDA 510(k) Clearance for its Plaque Analysis and RoadMap™ Analysis
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 received U.S. Food and Drug Administration (FDA) 510(k) clearance on […]
UPDATE – scPharmaceuticals Announces FDA Approval of FUROSCIX® (furosemide injection), the First and Only Self-administered, Subcutaneous Loop Diuretic for the At-home Treatment of Congestion in Chronic Heart Failure
FUROSCIX demonstrated 99.6% bioavailability and produced similar diuresis and natriuresis compared to intravenous furosemide Commercial launch planned in Q1 2023 BURLINGTON, Mass., Oct. 10, 2022 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of […]
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