Aurora Diagnostics Appoints Michael Grattendick as New CFO July 11, 2016 Previously, Grattendick served as the company’s vice president of finance, controller and treasurer. Read More
QT Vascular’s Chocolate Heart Drug-coated Balloon Wins CE Mark Clearance July 11, 2016 The balloon features a “nitinol-constraining structure.” Read More
St. Jude Medical’s SyncAV CRT Software Scores FDA Approval July 11, 2016 The latest addition bolsters the company’s cardiac resynchronization therapy portfolio. Read More
Qiagen Earns Warning Letter Over TB Test Failures July 8, 2016 The FDA issued a scathing warning letter to Germany-based Qiagen for numerous quality system failures related to its QuantiFeron TB test. Read More
EU Device Rules Move Forward, As Trilogue Members Agree to Updates July 8, 2016 It’s the final countdown for those long-awaited updates to regulations governing medical devices and in vitro diagnostics in Europe. Read More
MHRA Issues Warning on TRUEyou Glucose Strips July 8, 2016 The agency says certain lots of the blood glucose tests strips may give incorrect readings. Read More
India Abandons 75-Year Old Drug/Device Legislation July 8, 2016 Indian regulators have decided to abandon a proposed law to pursue more extensive revisions. Read More
Ireland Regulator Releases Safety Notice for Rapid Tests July 8, 2016 Ireland regulators are temporarily banning the use of three Biotest RightSign rapid tests. Read More
HeartWare Broadens Recall for Batteries July 8, 2016 The recall extends to 18,631 units nationwide. Read More
FDA Gives Thumbs Up to Corneal Implant July 8, 2016 The corneal implant is designed to improve near vision in patients with presbyopia. Read More
Spot On Sciences Earns Warning Letter Over Marketing Slips July 7, 2016 The company marketed its products for diagnostic testing. Read More
FDA Issues Warning Over Leukotrap RC System Blood Filters July 7, 2016 The company initially alerted healthcare providers in a recall notice dated June 8. Read More