Regulatory and Compliance
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 17, 2016
Marie Thibault FDA has published a draft guidance document explaining its perspective on diagnostics devices that use next-generation sequencing to identify...
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...
May 16, 2016
What is behind the public's wariness of the 21st Century Cures Act? Jim Dickinson As many in industry look forward hopefully to the enactment of the...
May 10, 2016
Marie Thibault TransEnterix still anticipates submitting a 510(k) application for the ALF-X System this year. The SurgiBot System did not receive 510(k)...
May 09, 2016
A top CDRH official answers our questions on pressing issues in digital health regulation at FDA. Marie Thibault Interoperability, mobile medical apps, and...
May 05, 2016
Marie Thibault Putting to rest some speculation about what the initiative’s future will be, a CMS leader confirmed today that the Parallel Review program will...
Apr 29, 2016
Marie Thibault Dexcom has long envisioned a future where patients with diabetes don't need confirmatory fingersticks to make decisions about their treatment....
Apr 27, 2016
Why doesn't FDA mention its own human factors guidance in another recent technology-specific guidance document? William A. Hyman On April 20, 2016, FDA issued...
Apr 25, 2016
Marie Thibault Congress has focused in recent years on easing the regulatory burden for medical device makers. But since reimbursement hurdles often outweigh...