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
French Devicemaker Lands Warning Letter for Validation, CAPA Failures July 7, 2016 The devicemaker failed to validate equipment and computer software. Read More
Electrosurgical Device Classified as Class II July 7, 2016 Electrosurgical devices use radiofrequency energy to produce localized heating. Read More
CMS Releases 2015 Analysis of Vendor-Provider Transactions July 7, 2016 Physicians and hospitals in the U.S. accepted $7.52 billion in payments. Read More
Prism’s ProteXsure System Scores FDA Clearance July 6, 2016 The system only requires one hand to operate. Read More
Luminex Gains FDA Clearance and CE-IVD Mark July 6, 2016 The system will be presented at the AACC Annual Scientific Meeting & Clinical Lab Expo. Read More
FDA Publishes Spring Modifications to Recognized PMA Standards July 6, 2016 The spring 2016 standards list features 32 modifications. Read More
U.S. Supreme Court to Review DNA Test Kit Patent Battle July 6, 2016 The case between Life Technologies and Promega involves genetic testing technology. Read More
General Medical Lands Warning Letter Over Complaint Handling, QS Failures July 6, 2016 The company develops devices for excessive sweating. Read More