The Latest Cardiac and Vascular News
Lava® LES is the first liquid embolic product approved by the FDA for use in the peripheral vasculature HAYWARD, Calif., April 18, 2023 /PRNewswire/ — Bay Area-based BlackSwan Vascular, Inc., a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval […]
Part of RapidAI’s industry-leading stroke solution, Rapid NCCT Stroke supports faster treatment and transfer decisions while driving greater equity of care SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA 510(k) clearance for Rapid NCCT […]
Designation represents progress for patients with suspected Coronary Microvascular Dysfunction as the FDA recognizes disease’s debilitating impacts and the lack of effective non-invasive options for efficient diagnosis MASON, Ohio–(BUSINESS WIRE)–Genetesis, Inc., the leader in biomagnetic cardiac imaging solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted […]
HOUSTON–(BUSINESS WIRE)–IPS HEART has been granted rare pediatric drug designation by the FDA for GIVI-MPC, a first-in-class stem cell therapeutic to create new skeletal muscle with 100% full length dystrophin and for ISX9-CPC, a first-in-class stem cell therapeutic for creating new functional cardiac muscle for the treatment of patients with Duchenne […]
QUEBEC CITY, April 6, 2023 /PRNewswire/ — Icentia Inc., today announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. “This approval marks a key milestone for our company. The FDA clearance opens the door to the world’s largest […]
Announces Receipt of Positive Formal FDA Feedback via the Q-Submission Program Substantially reduces the anticipated time and cost needed to receive a PMA EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that it has […]
GOTHENBURG, Sweden, March 24, 2023 /PRNewswire/ — Getinge’s iCast™ covered stent system has received premarket approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease. Iliac arterial occlusive disease is a type of peripheral arterial disease (PAD), a serious condition that only in the US […]
Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH), an inherited condition characterized by extremely high low-density lipoprotein cholesterol (LDL-C) 48% reduction in LDL-C from baseline at week 24 when Evkeeza was added to other lipid-lowering therapies in the pivotal trial TARRYTOWN, N.Y., March 22, […]
New artificial intelligence algorithm flags and triages suspected abdominal aortic aneurysms SAN FRANCISCO – March 21, 2023- Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm […]
The Oxford, UK headquartered company, long established as a market leader in Europe and a pioneer in the development of innovative stroke AI solutions, is now poised to take its transformative technology to US stroke centers OXFORD, England, and CHICAGO, March 21, 2023 /PRNewswire/ — Brainomix, the AI-powered medtech solutions company, today announced that its Brainomix 360 […]
