September 26, 2017 By The U.S. Food and Drug Administration Bridge Occlusion Balloon Catheter Recalled
August 15, 2017 By The U.S. Food and Drug Administration Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to Risk of Valve Failure Preventing Balloon Inflation and Deflation
June 23, 2017 By The U.S. Food and Drug Administration FDA Voice Blog: Fostering Medical Innovation: A Plan for Digital Health Devices
June 16, 2017 By The U.S. Food and Drug Administration FDA Expands Use of Sapien 3 Artificial Heart Valve for High-Risk Patients
May 25, 2017 By The U.S. Food and Drug Administration HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: Class I Recall – Due to Risk of Patient Injury and/or Death During Backup Controller Exchange
May 24, 2017 By The U.S. Food and Drug Administration Respironics California Recalls the V60 Non-invasive Ventilator Due to Faulty Cable Pins That May Cause the Device to Shut Down Unexpectedly
May 9, 2017 By The U.S. Food and Drug Administration Newport Medical Instruments Inc. Recalls Newport HT70 and Newport HT70 Plus Ventilators
April 12, 2017 By The U.S. Food and Drug Administration “Organs-On-Chips” Technology: FDA Testing Groundbreaking Science
March 1, 2017 By The U.S. Food and Drug Administration FDA Allows Marketing of Test to Identify Organisms That Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results
February 28, 2017 By The U.S. Food and Drug Administration Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery
February 28, 2017 By The U.S. Food and Drug Administration Zimmer Biomet Recalls Comprehensive Reverse Shoulder Due to a High Fracture Rate
February 24, 2017 By The U.S. Food and Drug Administration FDA-Approved Devices That Keep the Heart Beating
February 17, 2017 By The U.S. Food and Drug Administration FDA Permits Marketing of First Newborn Screening System for Detection of Four, Rare Metabolic Disorders
January 31, 2017 By The U.S. Food and Drug Administration Statement from FDA Commissioner Robert Califf, M.D. Announcing New Draft Guidances on Medical Product Communications
