Regulatory and Legal
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
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 12, 2016
Marie Thibault The reimbursement process for healthcare technology can be confusing even for experts and industry insiders. That has troubled legislators,...
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 16, 2016
Marie Thibault Recognizing the fast pace of advancement in software development, FDA is searching for the best way to regulate higher-risk medical software...
Jun 01, 2016
Marie Thibault For more than two decades, FDA has been categorizing investigational medical devices as either Category A (experimental/investigational) or...
May 27, 2016
Marie Thibault Women's health devices have been in the spotlight in recent years for all the wrong reasons. Laparoscopic power morcellators fell out of favor...
May 18, 2016
Marie Thibault In good news for patients and companies, medical device recalls dropped last quarter to the lowest level since 2013. According to the Q1 2016 U...
May 16, 2016
Marie Thibault Legislators in the House of Representatives have banded together to introduce a bill that would delay Medicare reimbursement cuts, in order to...