– 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. […]
Regulatory
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 […]
Correvio Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events
NASDAQ: CORV TSX: CORV VANCOUVER, Dec. 24, 2019 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Brinavess™ (vernakalant IV), an anti-arrhythmic […]
FDA Grants ‘Breakthrough’ Designation to Eko’s ECG-based Low Ejection Fraction Screening Algorithm, Designed to Improve Detection of Heart Failure
Developed in collaboration with Mayo Clinic, the algorithm would help healthcare providers detect heart failure during a standard physical exam San Francisco, CA, Dec. 18, 2019 (GLOBE NEWSWIRE) — Eko, a digital health company applying artificial intelligence (AI) in the fight against heart disease, today announced the U.S. Food and Drug Administration […]
TransThera Biosciences Announces IND Approval from FDA for Clinical Studies of TT-00920 to Treat Chronic Heart Failure
NANJING, China, Dec. 16, 2019 /PRNewswire/ — TransThera Biosciences Co. Ltd, a clinical-stage biotechnology company based in Nanjing, China, announced today that the U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for TT-00920, a novel small molecule inhibitor of Phosphodiesterase 9 (PDE 9) for the treatment of chronic heart failure. […]
First Patient Enrolls in STEMI DTU Randomized Controlled FDA Trial; Study Aims to Further Demonstrate Impella’s Safety and Effectiveness
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT), which will explore whether unloading the heart’s left ventricle for 30 minutes with an Impella heart pump prior to opening blocked arteries will reduce infarct size after a heart attack and lead to […]
FDA Clears Two Siemens Healthineers CT Systems Dedicated for Radiation Therapy Planning
• SOMATOM go.Sim and SOMATOM go.Open Pro help customers meet challenges in RT treatment planning The U.S. Food and Drug Administration (FDA) has cleared the SOMATOM go.Sim and SOMATOM go.Open Pro – two computed tomography (CT) systems from Siemens Healthineers that are dedicated for radiation therapy (RT) planning. The 64-slice SOMATOM […]



