Regulatory and Compliance
Jul 22, 2016
Marie Thibault Dexcom wants U.S. patients to be able to use its G5 Mobile Continuous Glucose Monitoring system to make insulin dosing and treatment decisions...
Jul 19, 2016
This amendment clarifies the original intent of the third edition of the electrical safety standard, and some regulatory bodies have already started...
Jul 19, 2016
Marie Thibault The push to add implantable medical device unique device identifiers (UDIs) to insurance claims forms is gathering steam. The effort has been...
Jul 18, 2016
Problems related to production controls account for almost a quarter of medical device recalls, and three failure modes are to blame in more than two-thirds of...
Jul 12, 2016
Marie Thibault The reimbursement process for healthcare technology can be confusing even for experts and industry insiders. That has troubled legislators,...
Jul 07, 2016
Software-related recalls have jumped 111% since 2010. Here’s what’s behind the increase. Joshua R. Dix, Suraj Ramachandran, Darin S. Oppenheimer Editor's Note...
Jul 07, 2016
Would-be manufacturers of antimicrobial-treated devices should familiarize themselves with seven important FDA requirements for 510(k) submissions for these...
Jul 05, 2016
Marie Thibault Abbott's Absorb GT1 Bioresorbable Vascular Scaffold System is the first U.S.-approved fully-dissolving coronary stent. Absorb, Abbott's...
Jun 29, 2016
Marie Thibault New findings published by The BMJ may give some proponents of speedy device approvals pause. It's well-known that high-risk medical devices...
Jun 27, 2016
FDA cited device-design issues as one reason medical device recalls are on the rise. Here’s how manufacturers can stop these problems from reoccurring. Joshua...