EU Grants CE Mark to St. Jude Medical’s Full Body MR Conditional Labeling for the Proclaim Elite System December 8, 2016 The nerve-stimulating therapy device reduces chronic pain. Read More
EMA Lays Out First Steps in Implementing ISO Standards for Drug Identifiers December 8, 2016 The EMA released details on two of the four SPOR data sets. Read More
Chinese Regulators Fine Medtronic $17M for Price Fixing December 7, 2016 Medtronic had been setting market prices for cardiovascular and diabetes devices since 2014. Read More
Former FDA Official Strikes Settlement with SEC Over Insider-Trading December 7, 2016 Gordon Johnston will pay $108,000 to resolve the allegations. Read More
Invendo Medical Nabs CE Mark for Invendoscope SC200 December 6, 2016 The device is for single-use only. Read More
FDA Hands Warning Letter to STI Pharma for Deficiencies in Reporting Adverse Events December 6, 2016 The company did not properly evaluate several of the ADEs it received. Read More
Kyocera Medical Gets FDA Clearance for Initia Hip System December 5, 2016 The Initia system includes zirconia-coated alumina ceramic femoral heads. Read More
Discontinued Formulation of Protonix IV Is Unsafe for Generics, FDA Says December 5, 2016 FDA chemists observed a presence of solid and liquid particles above acceptable limits. Read More
Nanowear Attains FDA Clearance for SimplECG December 2, 2016 The device is to be warn under your clothes on a daily basis. Read More
Indian State Authorities Report 27 Drugs from Leading Firms Failed Quality Tests December 2, 2016 There are five drugmakers drawing scrutiny from the state authorities. Read More
FDA Approves Cardiac Dimensions Trial for Heart Valve Repair Device December 1, 2016 The device is designed to redirect the blood flow into the heart. Read More
EMA Finalizes Guideline on Evaluating New and Existing Active Chemical Substances December 1, 2016 The guideline does not apply to herbal, biological, biotechnological products, radiopharmaceuticals and radiolabeled products. Read More