Court Consolidates Class Action Suits Against Theranos August 25, 2016 A federal judge combined six class actions that allege fraud and false advertising. Read More
Expert Advice on Getting Medical Device Reviews ‘Inspection Ready’ August 24, 2016 Complaints are one of the most commonly cited sections in FDA device warning letters. Read More
Earth Science Tech Acquires Canadian Biotech Company BEO-ITS August 24, 2016 The Canadian biotech company develops devices for sexually transmitted infections. Read More
Oculus Secures FDA Clearance for Post-Dermal Device August 24, 2016 The device is designed to remove foreign material and debris after dermal procedures. Read More
Amedica Earns FDA Clearance for Expanded Sizes of Valeo II Lateral Lumbar Device August 24, 2016 The expanded sizes are intended to accommodate a broader range of patient anatomies. Read More
FDA Awards Ninth EUA for Zika Dx August 23, 2016 InBios International's Zika diagnostic yielded the FDA authorization to confirm the presence of Zika virus antibodies. Read More
FDA Categorizes Devices as Class II August 23, 2016 FDA determined the classification of de novo requests. Read More
UK Issues Alert on Underdosing With Roche’s Accu-Check Insulin Pump August 23, 2016 Cartridges inserted incorrectly can leak insulin. Read More
FDA Advisors Back Approval of Baebies’ Seeker Analyzer for Newborns August 23, 2016 The FDA committee unanimously recommended the product for approval. Read More
FDA Extends Comment Period for Infectious Disease Diagnostic Guidance August 22, 2016 The new deadline is Sept. 12. Read More
FDA Issues More Warnings on Custom Ultrasonics Reprocessors for Duodenoscopes August 22, 2016 Company provides labels to deter use of reprocessors on duodenoscopes. Read More
Edwards Transcatheter Heart Valves Approved in Intermediate-Risk Patients August 22, 2016 The FDA lowers the risk level required for use of the heart valves. Read More