Claret Medical Gains FDA Clearance for Its Sentinel Cerebral Protection System June 5, 2017 The Sentinel is positioned away from the aortic arch. Read More
Drugmaker Warned Over Long-Term Quality Problems June 5, 2017 The plant had failed to comply with current good manufacturing practices. Read More
Cardiac Troponin Test Receives CE Mark June 2, 2017 The Singulex Sgx Clarity cTnl assay measures the biomarker troponin. Read More
EMA Accepts Five Drugs for Priority Medicine Program June 2, 2017 The five new products granted PRIME eligibility cover various diseases and conditions. Read More
OrthoAccel's AcceleDent Optima Gains FDA Clearance June 1, 2017 The orthodontic device directly connects patients and practices with usage monitoring. Read More
Drugmaker Warned for Lack of Product Testing June 1, 2017 The agency found the facility did not perform or document proper testing of drug components. Read More
Atonomics Gains CE Mark For Trace Lipids Test Panel May 31, 2017 The lipids panel determines total cholesterol. Read More
Roche Investigating Case of PML From Recently Approved Drug May 31, 2017 The patient was previously treated with Biogen’s Tysabri. Read More
Ra Medical Systems Achieves FDA Clearance For Peripheral Artery Disease Treatment May 30, 2017 The device is a catheter and laser system for the treatment of arterial blockages in the lower vessels. Read More
EMA Issues Guideline for Reporting Clinical Trial Protocol Breaches May 30, 2017 A breach is considered serious if it is likely to affect a trial subject’s safety. Read More
Quidel Awarded PMDA Approval for Its Sofia Influenza A+B Assay May 25, 2017 Sofia analyzer and Sofia influenza A+B FIA uses software and fluorescent chemistry to yield results. Read More
HHS Delays 340B Overcharging Penalties Until October May 25, 2017 The final rule includes civil penalties a 340B provider paid a manufacturer more than the established ceiling price for a single drug. Read More