The Latest Cardiac and Vascular News
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 […]
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 […]
Pivotal study expected to be completed by year-end 2023 and set the stage for commercialization of PerQseal® system for large hole vessel closure Company announces €30 million strategic investment from Haemonetics as part of its previously disclosed Series D financing GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical® Limited (“Vivasure” or the “Company”), a company pioneering novel […]
LONDON–(BUSINESS WIRE)–LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz™ Heart-Lung Machine (HLM). With FDA clearance, LivaNova initiates the commercial launch of Essenz in the U.S. The Company also recently received approval for […]
Swoop® Portable MR Imaging® system positioned to offer even greater clinical utility in neurocritical care GUILFORD, Conn., Feb. 28, 2023 (GLOBE NEWSWIRE) — Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable MRI system, today announced the U.S. Food and […]
SEOUL, South Korea, Feb. 21, 2023 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) has submitted a confirmatory pivotal Phase 3 Clinical Trial in Fontan subjects to the Food and Drug Administration (FDA). In the Type B meeting between the FDA and Mezzion, the FDA provided Mezzion with a clear path forward […]
Irish-based company secures first U.S. regulatory clearance for its Millipede 088 Access Catheter from the Food and Drug Administration (FDA) The company is also developing catheter-based technology for treating acute ischemic stroke GALWAY, Ireland–(BUSINESS WIRE)–Perfuze, a medical device company developing next-generation catheter-based technology to treat acute ischemic stroke, has secured […]
