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 […]
Peripheral/Endo
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 […]
VESTECK Scientific Advisory Board members address significant global unmet need
WEST CHESTER, Pa., Aug. 28, 2023 /PRNewswire/ — In response to a significant global unmet need for the “SUTURE-TIGHT”™ catheter, VESTECK, Inc. is expanding the International Scientific Advisory Board. VESTECK Scientific Advisory Board members address significant global unmet need We are honored to have Professor Dainis Krievins, from Latvia, Canadian, Dr. Bao Bui and Australian, Professor […]
Nectero Medical Receives FDA Fast Track Designation for Nectero EAST® System
TEMPE, Ariz.–(BUSINESS WIRE)–Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System to treat patients with infrarenal AAAs, maximum diameter 3.5 – […]
Instylla Announces Completion of $30MM EQUITY Financing
BEDFORD, Mass., Aug. 15, 2023 /PRNewswire/ — Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced the closing of a $30 million financing round. This financing round was led by new investor, Delos Capital, with continued participation from the investor syndicate of Excelestar Ventures, Ascension Ventures, Catalyst Health […]
MedAlliance announces the completion of enrollment in SAVE Trial with SELUTION SLR for Treatment of AV Fistulas in Renal Dialysis Patients
GENEVA, Aug. 15, 2023 /PRNewswire/ — MedAlliance has announced completion of patient enrollment in the SAVE Clinical Trial with the SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of failed AVF (arteriovenous fistulas) in renal dialysis patients. SELUTION SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of […]
MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon
WASHINGTON, Aug. 7, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH) is pleased to announce its role in the successful […]
Merit Medical’s WRAPSODY™ Arteriovenous Access Efficacy (WAVE) Pivotal Study Completes Enrollment
SOUTH JORDAN, Utah, Aug. 03, 2023 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced the completion of enrollment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study. Merit’s WAVE study is a prospective, randomized, controlled, multicenter study comparing […]
Society for Vascular Surgery Responds to New York Times Article on Overuse of Interventions in Vascular Surgery
ROSEMONT, Ill., July 31, 2023 /PRNewswire/ — The Society for Vascular Surgery (SVS), the leading medical organization dedicated to advancing quality in vascular health care, has issued a response to a recent New York Times article detailing allegations of overuse of interventions to treat patients with peripheral vascular disease. SVS sent a strong message that it is inaccurate […]