SAN DIEGO & SHANGHAI–(BUSINESS WIRE)– Sirius Therapeutics, announced it has dosed the first subject in a Phase 1, first-in-human clinical trial in Australia of SRSD107 on January 30th 2024, its next generation siRNA therapeutic targeting coagulation Factor XI (FXI), for the prevention and treatment of thromboembolic disorders. SRSD107 is the second clinical […]
Regulatory
GORE RECEIVES FDA APPROVAL FOR BREAKTHROUGH ENDOVASCULAR DEVICE IN COMPLEX AORTIC ANEURYSMS
The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis approval brings the first branched, all-in-one solution for patients with thoracoabdominal aortic aneurysms and high-surgical risk patients with pararenal aortic aneurysms in patients with appropriate anatomy. “TAMBE is an innovative first step forward that enables us to provide care that’s both effective and timely for […]
CroíValve Announces FDA IDE Approval and Initiation of its Early Feasibility Study
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 […]
HeartFlow Announces New Reimbursement Code and Increased Payment for FFRCT
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 […]
AngioDynamics Announces FDA 510(k) Clearance of Auryon XL Radial Access Catheter to Treat Peripheral Arterial Disease
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, […]
Nectero Medical Announces Initiation of Phase II/III Clinical Trial of the Nectero EAST® System for Treatment of Small- to Medium-Sized Abdominal Aortic Aneurysms
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,
Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System for Treating de novo or Restenotic Below-the-Knee (BTK) Lesions
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 […]
Endovascular Engineering’s Hēlo™ Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism
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…
Arch Biopartners Receives Health Canada Approval to Conduct Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury
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 […]
Biosense Webster Announces Regulatory Approval of VARIPULSE™ Pulsed Field Ablation (PFA) Platform in Japan
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)…
Recent
Popular
- No commented posts yet