The Latest Cardiac and Vascular News
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 […]
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) today announced the U.S. Food and Drug Administration (FDA) has […]
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 IND application to the FDA in 2023 SOUTH SAN FRANCISCO, […]
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 […]
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 named a 2022 Fierce Life Sciences Innovation Awards winner in the Medical […]
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 superficial femoral artery and the popliteal artery. The Chocolate […]
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 United States when its scientific teams spoke last week at […]
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 […]
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 calcified cardiovascular disease, dilate stenosed intimal hyperplasia, and access, cross, […]
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 […]
