The Latest Cardiac and Vascular News
DUBLIN–(BUSINESS WIRE)–CroíValve, an Irish-U.S. based medical device company with a novel, transcatheter solution for tricuspid regurgitation (TR), today announced initiation of its Early Feasibility Study (EFS) for the DUO™ Tricuspid Coaptation Valve System, following FDA IDE and CMS approval. The TANDEM II trial is a prospective, multi-center, non-randomized single-arm study […]
MOUNTAIN VIEW, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) — HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) precision coronary solutions, announced FFRCT was transitioned to a Category I Current Procedural Terminology (CPT®) code beginning January 1, 2024. The new code, designated by The American Medical Association (AMA), supports FFRCT […]
LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced that the United States Food and Drug Administration (FDA) has cleared the Auryon XL Catheter, […]
TEMPE, Ariz.–(BUSINESS WIRE)– #AbdominalAorticAneurysm–Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease and improve patients’ lives, today announced initiation of a Phase II/III clinical trial (stAAAble) to investigate the safety and efficacy of the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5 – 5.0cm. The Nectero EAST System is a single-use,
San Clemente, CA—Jan. 15, 2024 – Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System. The device is intended to treat de novo or restenotic lesions […]
MENLO PARK, Calif., Jan. 11, 2024 /PRNewswire/ — Endovascular Engineering (“E2”), a medical device company focused on the development and deployment of groundbreaking clot removal technologies that target venous thromboembolism (VTE), announced today FDA Investigational Device Exemption…
TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated […]
First regulatory approval for the first-of-its-kind, fully-integrated PFA system with a simple and reproducible workflow Integrated with the world’s leading CARTO™ 3D cardiac mapping system for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib)…
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the American Medical Association (AMA) has assigned a dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analysis (PLA), 0440U, for the company’s AI-driven coronary heart disease (CHD) detection test, PrecisionCHD. Receipt of this new CPT […]
HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel […]
