HHS Mandate to Furnish Full Trial Results Backed With Funding Sanctions October 7, 2016 All clinical trials must register and publish their results in the public database in a timely manner. Read More
Baxter Recalls Micron Filter Due to Potential for Missing Filter Membrane, Contamination October 6, 2016 The device component is used to filter bacteria and other microscopic matter. Read More
FDA Issues Recall for Twin-Pass Dual Access Catheters October 6, 2016 The recalled products were manufactured from October 2014 to August 2016. Read More
Australia Releases Alert on Stryker Femoral Heads October 6, 2016 Device components are used in total hip replacement procedures. Read More
Hong Kong Issues Warning of Electric Shock With Medela Breast Pump October 6, 2016 The manufacturer is launching a voluntary replacement program for the detachable power plugs. Read More
Siemens Gets FDA Marketing Clearance of the Xprecia Stride Coagulation Analyze Device October 5, 2016 The device uses fresh capillary whole blood, and results are expressed as INR. Read More
Nurse Assist Issues Nationwide Recall of All Unexpired Lots of IV Flush Syringes October 5, 2016 The recall consists of 3mL, 5mL and 10mL IV flush syringes. Read More
Explosion Risk Prompts Recall of DePuy Surgical Battery Adapters October 5, 2016 The FDA has identified this as a Class I recall. Read More
China Proposes Broader Criteria, Higher Penalties for Device Recalls October 5, 2016 The proposed rules change the standards for when a recall would be required. Read More
FDA Grants Approval to Valencia’s eCoin Neurostim Trial October 4, 2016 Pre-clinical trial revealed a reduction in systolic blood pressure of 7.3mm Hg at 3 months. Read More
St. Jude Medical Receives FDA Approval for BurstDR Spinal Cord Stimulation October 4, 2016 The device sends out intermittent pulses designed to mimic the body’s natural nerve impulse patterns. Read More
J&J Cautions Insulin Pump Users of Cyber Risk October 4, 2016 About 114,000 patients in the U.S. and Canada use the device. Read More