EyeYon medical Ltd. announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its EndoArt®, Artificial Endothelial Layer Implant.
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CARDIOFOCUS: Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System
CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the company has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of AFib.
MOST SACRED HEART OF JESUS CARDIOLOGY AND VALVULAR INSTITUTE: Dr. Rajamannan Sends Over to the FDA Commissioner the US Senate Finance Investigation Files to Help the FDA's Review of Newly Discovered Design Control Study in Chicago
Minneapolis FDA delays reporting to the patients in Chicago the non-exempt testing of the device affecting 667 patients