The Latest Cardiac and Vascular News
SUNNYVALE, Calif.–(BUSINESS WIRE)–Embolx, Inc., a medical device company developing microcatheters for arterial embolization procedures, today announced that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its next generation family of Sniper® Balloon Occlusion Microcatheters, an innovative system for pressure-directed arterial embolization therapy. […]
BREA, Calif., June 27, 2018 /PRNewswire/ — Beckman Coulter Diagnostics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new high-sensitivity troponin (hsTnI) assay, Access hsTnI, for use on the Access 2, DxI and the entire Access family of immunoassay systems. The Access hsTnI assay […]
SAN JUAN CAPISTRANO, Calif.–(BUSINESS WIRE)–Avenu Medical, Inc. announced today that it has received De Novo marketing authorization from the Food and Drug Administration (FDA) to market its Ellipsys® Vascular Access System, an innovative, minimally-invasive catheter-based system designed for End-Stage Renal Disease (ESRD) patients requiring hemodialysis. The FDA’s action will provide U.S. […]
SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc. announced today it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the IMPEDE Embolization Plug. The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is available in […]
BASKING RIDGE, N.J., June 19, 2018 (GLOBE NEWSWIRE) — Caladrius Biosciences, Inc. (Nasdaq:CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company with multiple technology platforms targeting select cardiovascular indications and autoimmune diseases, announces today that the U.S. Food and Drug Administration (“FDA”) has granted regenerative medicine advanced therapy (“RMAT”) designation to […]
HOUSTON, TX, June 18, 2018 (GLOBE NEWSWIRE) — AngioSoma, Inc. (SOAN) is excited to announce that we have identified a regulatory firm who can assist taking our patented flagship drug, Liprostin™, through the FDA approval process. The regulatory firm will begin with a presubmission meeting with the FDA biologic group […]
DUBLIN, Ohio, June 12, 2018 /PRNewswire/ — Cardinal Health (NYSE: CAH) today announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has provided a favorable recommendation on the premarket approval application for INCRAFT® AAA Stent Graft System (INCRAFT). The panel voted 11 to 4 in […]
LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced it received FDA 510(k) clearance for its MEMO 4D® semi-rigid mitral annuloplasty ring and confirmed the first implantation of the device. MEMO 4D, LivaNova’s next-generation of the MEMO device family, now offers a broader range of […]
ALISO VIEJO, Calif., June 12, 2018 /PRNewswire/ — MicroVention, Inc. a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA clearance of a new clinical indication for the SOFIA® Catheter (Soft TOrqueable catheter For Intracranial Access) to include contact aspiration technique for successful revascularization among patients with acute ischemic stroke, secondary to intracranial large […]
VANCOUVER, June 11, 2018 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a revenue-generating, specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients, today announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the regulatory […]
