Regulatory

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 (TAVR) system for the treatment of aortic valve disease, announced […]

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 treat peripheral artery disease (PAD) of the lower extremities, a […]

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 Catheters and Separators are indicated for the removal of fresh, […]

MicroVention Announces FDA Premarket Approval of a New Flow Diverter for the Treatment of Brain Aneurysms

Aliso Viejo, CA. – January 9, 2020 –MicroVention, Inc., a U.S. based subsidiary of Terumo and a global neurovascular company announced the FDA Premarket Approval (PMA) for the FRED® (Flow Re-Direction Endoluminal Device) device for the treatment of brain aneurysms.   The FRED® device is the first flow diverter in the U.S. to use […]

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 valvular heart disease in Most Sacred Heart of Jesus Cardiology, […]

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 the optimal surgical method for their patients ABBOTT PARK, Ill., Jan. […]

AtriCure Announces Successful Completion of Patient Enrollment of aMAZE Clinical Trial and FDA Approval of Continued Access Protocol

MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced the successful completion of patient enrollment in the aMAZE™ clinical trial. In addition, the company announced that it has received approval from the Food and Drug Administration […]

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 are tested and safe, as the Food and Drug Administration […]

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 of refractory angina, today announced the submission of a Premarket […]

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. Food and Drug Administration (FDA) pursuant to an Investigational New […]