The Latest Cardiac and Vascular News
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 […]
If approved, Evkeeza would be the first and only treatment of its kind to help children as young as 5 years old control dangerously high levels of LDL cholesterol caused by homozygous familial hypercholesterolemia TARRYTOWN, N.Y., Nov. 30, 2022 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) […]
TN-401 is being developed for the treatment of genetic arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by mutations in the PKP2 gene Orphan Drug Designation for TN-401 is the first for a gene therapy treatment for ARVC Expect to submit TN-401 […]
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 […]
KardiaMobile Card recognized for its impact in improving personal cardiac monitoring MOUNTAIN VIEW, Calif., Nov. 17, 2022 /PRNewswire/ — AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced that KardiaMobile Card, the world’s first credit-card-sized, FDA-cleared personal ECG device, has been […]
SINGAPORE, Nov. 11, 2022 /PRNewswire/ — Genesis MedTech Group announced today that the Food and Drug Administration (FDA) has approved the Chocolate Touch® Drug-coated Balloon PTA Catheter, developed by TriReme Medical LLC, for the treatment of patients with peripheral artery disease in […]
The South Korean, AI diagnostics company aims for FDA approvals to increase non-invasive, early detection to save lives Seoul, South Korea – November 10, 2022 – Mediwhale, the AI-empowered health diagnostics company based in South Korea, made waves in the […]
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 […]
Transformative XO Angioplasty Platform Expands with Low-Profile 2.2F and 3.8F Rapid-Exchange (RX) with the Ability to Treat Up to 20cm Lesions with (1) Inflation SALT LAKE CITY, Oct. 27, 2022 /PRNewswire/ — Transit Scientific, a pioneer in developing medical devices to treat […]
