FDA Exempts Low-Risk Wellness Devices From Regulation August 3, 2016 CDRH says wellness devices are intended only for general wellness use. Read More
Gore Gets FDA Approval for Tigris Vascular Stent August 2, 2016 The Tigris vascular stent is designed to adapt to the natural movement of the knee. Read More
Two BTG Products Get CE Mark Reclassifications as Class III Devices August 2, 2016 Reclassified drug-eluting beads used to load and release chemotherapy drugs. Read More
Boston Scientific Recalls Select Valves Due to Release Mandrel Breakage August 2, 2016 There have been numerous reports of catastrophic vessel trauma. Read More
UDI Guidance Covers Testing, Other Considerations August 2, 2016 Guidance seeks UDIs in two forms on product labels and packages. Read More
FDA Tweaks Guidance on Adaptive Designs for Device Studies August 2, 2016 Update takes into account comments the agency received on definitions and particulars. Read More
Stryker’s Catheter Breakage Prompts Recall August 1, 2016 Recall affects products distributed in 11 states over four years. Read More
Carefusion Issues Class I Recall on Laparoscopes, Ventilators August 1, 2016 Weld failure could result in a wire protruding through the tip of the instrument. Read More
J&J’s Acclarent Shells Out $18 Million to Resolve FCA Claims August 1, 2016 DOJ alleged that the company distributed an unapproved device. Read More
FDA Weighs How to Apply Real-World Evidence to Regulatory Calls August 1, 2016 Real-world evidence could prove sufficient for regulatory decisions. Read More
Devicemakers See Lower Fees in MDUFA 2017 August 1, 2016 Price for PMA to drop nearly $27,000 on Oct. 1. Read More
Australia Urges Caution With Reprocessed Duodenoscopes July 29, 2016 Two major manufacturers of duodenoscopes marketed in Australia have initiated recalls to address contamination after reprocessing. Read More