Regulatory and Legal
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...
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 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...
May 03, 2016
Marie Thibault Medtronic's Visia AF MRI SureScan and Visia AF single-chamber ICDs received FDA approval. FDA has approved a two-for-one technology, the Visia...
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
Marie Thibault The digital medicine combination of Proteus Digital Health's ingestible sensors and Otsuka Pharmaceutical's Abilify drug was the subject of an...