SAN CARLOS, Calif., Jan. 14, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph® DNA deflectable […]
Tag: FDA
FDA Grants Breakthrough Device Designation to Reflow Medical’s Temporary Spur Stent System
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and […]
JenaValve Transcatheter Aortic Valve Replacement (TAVR) System Designated by FDA as Breakthrough Device
JenaValve Pericardial TAVR System is the First Transcatheter Device to Achieve Breakthrough Device Designation; Prioritizes Premarket Approval Development Path for Severe Aortic Regurgitation Indication IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial transcatheter aortic valve replacement […]
Alucent Biomedical Announces FDA Approval to Proceed with Natural Vascular Scaffolding Clinical Trial
SALT LAKE CITY–(BUSINESS WIRE)–Alucent Biomedical Inc. has received U.S. Food and Drug Administration approval to proceed with a Phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology. The therapy is designed to […]
Penumbra Announces FDA Clearance of Indigo® Aspiration System for Treatment of Pulmonary Embolism
ALAMEDA, Calif.–(BUSINESS WIRE)–Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the Indigo® Aspiration System. As part of the Indigo Aspiration System, the Indigo Aspiration […]
FDA Confirms Non-Exempt Status of Medical Device but No Plans to Inform the Patients as Confirmed by Dr. Rajamannan in Press Conference at Most Sacred Heart of Jesus Cardiology and Valvular Institute
FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens. SHEBOYGAN, Wis., Jan. 9, 2020 /PRNewswire/ — Following recent reporting by Kaiser Health News that the FDA has lifted their exemption laws, Dr. Nalini Rajamannan a specialist for patients with […]
FDA Approves Less Invasive Surgical Approach for Abbott’s Heart Pump to Help Patients Avoid Open Heart Surgery
– For people battling advanced heart failure, Abbott’s HeartMate 3 heart pump can now be implanted through an incision in the chest wall versus open heart surgery – New, less invasive technique provides cardiac surgeons with the ability to choose […]
Dr. Nalini Rajamannan Comments on FDA Congressional Letter to Senate Finance Committee After Kaiser Health News Reveals Access to Exempt FDA Database
SHEBOYGAN, Wisconsin, Jan. 6, 2020 /PRNewswire/ — Dr. Nalini Rajamannan — a specialist for patients with valvular heart disease in Most Sacred Heart of Jesus Cardiology, Sheboygan, WI — confirms today that patients finally may get answers about whether medical devices placed in their bodies […]
Neovasc Submits Premarket Approval Application to FDA for Neovasc Reducer™
VANCOUVER, Dec. 31, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment […]
CryoLife Receives FDA Authorization to Commence PROACT Xa Clinical Trial
Study Designed to Evaluate the Use of Apixaban in On-X Aortic Valve Patients ATLANTA, Dec. 23, 2019 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has received authorization from the U.S. […]
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