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
Roundtable Healthcare Finalizes Acquisition of Symmetry Surgical July 5, 2016 The deal was first announced on May 2. Read More
FDA, Industry Make Strides on Case for Quality Guidance July 5, 2016 The agency expects to release draft guidance on quality metrics for devices within the next few months. Read More
Proposed Rule Calls for More Data on Imported Devices July 5, 2016 The rule calls for additional product identification information. Read More
FDA, Industry Inch Closer Toward MDUFA Agreements July 5, 2016 A MDUFA counter-proposal suggests a slowly closing gap between negotiations. Read More