Regulatory and Legal
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...
Apr 26, 2016
Marie Thibault Boston Scientific's Accolade MRI and Essentio MRI pacemakers, as well as the Ingevity MRI pacing leads received FDA approval.  FDA...
Apr 22, 2016
Marie Thibault FDA has proposed prohibiting electrical stimulation devices (ESD) used to treat aggressive or self-injurious behavior, a move that would...
Apr 20, 2016
Marie Thibault Fisher Wallace Laboratories, makers of the Fisher Wallace Stimulator, urged supporters to submit comments on the FDA proposal. Dozens of...
Apr 13, 2016
Marie Thibault A public-private partnership has put forth a draft blueprint intended to give medical device companies a helping hand in planning and...
Apr 12, 2016
Marie Thibault The Dexcom G4 Platinum receiver is one of the model types subject to the recall. Users have been urged to test the audio alert function. Dexcom...
Apr 08, 2016
Marie Thibault Abiomed announced Thursday that many of the devices in its Impella product line had received FDA approval for use in cardiogenic shock patients...
Apr 07, 2016
Marie Thibault In an April 6 FDA Voice blog post, the agency announced the formation of a Combination Products Policy Council, which will be able to make...
Apr 05, 2016
Marie Thibault A national medical device evaluation system (NMDES) is inching closer to reality. This week, a planning board report from the Duke-Margolis...