The Latest Cardiac and Vascular News
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 […]
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. 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 […]
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 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 […]
Smaller Sheath Simplifies Access and Improves Ease-of-Use DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath. Compared to the existing 14 French (Fr) sheath used for placement of Impella CP, the new sheath maintains the same inner […]
Medtronic “conduction system pacing” expanded indication now includes left bundle branch area pacing in addition to His-Bundle pacing for patients with slow heart rates DUBLIN, Oct. 17, 2022 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) approval for […]
