The Latest Cardiac and Vascular News
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardio Flow, Inc., a privately held medical device company and developer of minimally invasive devices to treat peripheral artery disease (PAD), today announced it recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. “Critical Limb Ischemia: Volume 1. […]
WILMINGTON, N.C., Oct. 17, 2023 /PRNewswire/ — Alcami Corporation (“Alcami”), a leading contract development and manufacturing organization (CDMO), today welcomed the recent announcement by Nectero Medical that they have received clearance from the U.S. Food and Drug Administration of their IND application to initiate Phase II/III trial of the Nectero Endovascular Aneurysm […]
SAN JOSE, Calif.–(BUSINESS WIRE)–Evident Vascular, Inc., a medical technology startup developing a next-generation intravascular ultrasound (IVUS) platform leveraging artificial intelligence to enable superior imaging and streamlined workflows, announced today that it has launched with a $35 million Series A financing from Vensana Capital®. “Legacy IVUS platforms were originally designed primarily for […]
TEL AVIV, Israel and MIAMI, Oct. 12, 2023 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced its support for the Centers for Medicare and Medicaid Services (CMS) final National Coverage Determination (NCD) which expands coverage […]
SOUTH JORDAN, Utah, Oct. 10, 2023 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced the expansion of its Maestro Microcatheter product line to now include a new longer length for radial embolization procedures. The Maestro is part of […]
BROOMFIELD, Colo., Sept. 28, 2023 /PRNewswire/ — Today, Alio, Inc. announces the release of a new feature for its remote monitoring platform which notifies clinical care teams when there is a gap in typical acoustic data from a patient’s vascular access site. While the platform was FDA-cleared in March of this year to […]
TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ — Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a Breakthrough Technology, was cleared based on […]
PARIS & SAN JOSE, Calif.–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved the LimFlow System to help people with […]
DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. The single-arm clinical […]
SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced that the Food and Drug Administration (FDA) granted investigational device exemption (IDE) for the company to begin a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device […]
