The Latest Cardiac and Vascular News
BOTHELL, Wash., March 23, 2017 /PRNewswire/ — Mirabilis Medical, a Seattle-area developer of advanced medical technology for non-invasive surgery, announced today CE Mark authorization for marketing of the Mirabilis System for treatment of uterine fibroids throughout the European Union. The company simultaneously announced that it had received approval from the US […]
ALBANY, N.Y., March 14, 2017 (GLOBE NEWSWIRE) — AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease and oncology/surgery, today announced it has received CE Mark certification for the Solero Microwave Tissue Ablation (MTA) System. The Solero MTA System and Accessories are […]
Press Release RESEARCH TRIANGLE PARK, N.C. — Humacyte, an innovator in biotechnology and regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted HUMACYL®, its investigational human acellular vessel (HAV), the Regenerative Medicine Advanced Therapy (RMAT) designation. This designation means that the FDA will help facilitate […]
VANCOUVER, British Columbia–(BUSINESS WIRE)–Aegis Medical Innovations Inc. (Aegis) today announced that it has received Investigational Device Exemption approval from the U.S. FDA to initiate a clinical trial in the U.S. for its medical device called the Sierra Ligation System (Sierra). Aegis developed the Sierra technology in partnership with the Mayo […]
BioStable Science & Engineering Announces FDA Clearance of the HAART™ 300 Aortic Annuloplasty Device AUSTIN, Texas–(BUSINESS WIRE)–BioStable Science & Engineering, Inc. announced today it has received FDA market clearance for the HAART 300 Aortic Annuloplasty Device, the first commercially available internal annuloplasty device designed for aortic valve repair. BioStable expects […]
Press Release Medtronic Receives FDA Approval for CoreValve(TM) Evolut(TM) Pro Transcatheter Valve with Advanced Sealing DUBLIN – March 22, 2017 – Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve(TM)Evolut(TM) PRO valve for the treatment of severe aortic stenosis for symptomatic […]
Toshiba Medical’s New Premium Cardiovascular Ultrasound Receives FDA Clearance The Aplio i900 Delivers Fast, High Quality Images for Better Diagnostic Confidence TUSTIN, Calif.–(BUSINESS WIRE)–Cardiologists can now access the advanced ultrasound imaging technology needed for fast and confident diagnoses with Toshiba Medical’s Aplio™ i900. The newly FDA-cleared system is the latest […]
PQ Bypass Announces CE Mark for DETOUR Percutaneous Bypass Technologies Trio of proprietary technologies expands treatment options for patients with extremely long superficial femoral artery blockages due to peripheral artery disease March 13, 2017 08:00 AM Eastern Daylight Time SUNNYVALE, Calif.–(BUSINESS WIRE)–PQ Bypass, today announced CE (Conformité Européenne) Mark approval […]
TEL AVIV, Israel–(BUSINESS WIRE) AV Medical Technologies announced on 27 February 2017 that its Chameleon PTA balloon catheter has received FDA clearance for an expanded indication to include infusion of diagnostic or therapeutic fluids. “The Chameleon balloon offers advantages for experienced operators as well as those training in dialysis access […]
View source version on businesswire.com: http://www.businesswire.com/news/home/20170314005152/en/ Teleflex Incorporated (TFX), a leading global provider of medical technologies for critical care and surgery, has announced 510(k) clearance by the Food and Drug Administration and U.S. commercial launch of the Spectre Guidewire. The Spectre Guidewire is engineered with a smooth stainless steel-to-nitinol dual-core […]
