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 […]
Peripheral/Endo
Merit Medical Launches Expanded Maestro® Microcatheter Line
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 […]
Alio’s Remote Monitoring Platform Now Notifies Clinicians of Atypical Acoustic Data from Patients with Vascular Access
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 […]
The VasQ™ External Support Now FDA Cleared for Use in Creating Arteriovenous Fistulas
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 […]
FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options
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 […]
Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma
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 […]
Shape Memory Medical Receives FDA IDE Approval to Initiate AAA-SHAPE, a Head-to-Head Trial
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 […]
VentureMed Group Receives European Medical Device Regulation (MDR) Certification for FLEX Vessel PrepTM System
Minneapolis, Minnesota, September 6, 2023 – VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that the company is an early recipient of MDR certification. Gaining MDR certification […]
Zylox-Tonbridge’s ZENFlow Tiger™ LD PTA Dilatation Catheter Receives ANVISA Marketing Approval
HANGZHOU, China, Aug. 30, 2023 /PRNewswire/ — Zylox-Tonbridge Medical Technology Co., Ltd. (2190.HK, hereinafter referred to as “Zylox-Tonbridge” or the “Company”) announced that its ZENFlow Tiger™ LD PTA Dilatation Catheter (hereinafter referred to as “ZENFlow Tiger™”), a product independently developed by the Company, has received marketing approval from ANVISA. The Company expects […]
Haemonetics Announces European Expansion for VASCADE® Vascular Closure System
BOSTON, Aug. 29, 2023 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, has announced that for the first time, patients have been treated with the company`s VASCADE MVP® Venous Vascular Closure system in Germany. This marks the first use of the […]
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