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FDA

By Laura Lovett | 05:09 pm | January 22, 2018
Nokia has announced that it will disable the pulse wave velocity measurement feature on its Withings’ Body Cardio scale as of January 24.
By Dave Muoio | 03:58 pm | January 15, 2018
Last September, Tidepool — a diabetes data management platform — was among the nine companies chosen to participate in the FDA’s experimental pre-certification program pilot.
By Jonah Comstock | 02:28 pm | January 19, 2017
Updated with statement from Eli Lilly Indianapolis-based pharma company Eli Lilly recently recieved FDA 510K clearance for a new mobile app called Go Dose, a diabetes management and insulin dosing app for users of Humalog, Lilly's rapid-acting insulin.
By Jonah Comstock | 03:40 pm | January 17, 2017
Last November, as part of an investigative series on Apple's meetings with the FDA, we reported the company's stated plans to develop "two possible (and related) products in the cardiac space" which would require FDA clearance.
By Heather Mack | 04:55 pm | January 16, 2017
Health enterprise SaaS company Welltok announced an expanded partnership with IBM Watson Health.
By Heather Mack | 03:42 am | January 11, 2017
IBM Watson Health has announced a joint initiative with the US Food and Drug Administration to study the use of blockchain technology to share health data to ultimately improve public health.
By Heather Mack | 02:53 pm | December 30, 2016
Over the past year, MobiHealthNews has covered 36 devices that received clearance from the Food and Drug Administration.
By Jonah Comstock | 02:42 pm | December 30, 2016
Over and above clearing a number of devices, the FDA had a busy year in 2016, passing a number of draft and final guidances related to digital health, having some notable conversations with vendors, and even turning down some devices whose FDA clearance was expected this year.
By Jonah Comstock | 02:26 pm | January 13, 2016
Neurometrix has received FDA clearance for a new smartphone-controlled version of Quell, its wearable for pain relief, the company announced last week.
By Aditi Pai | 10:18 am | December 02, 2015
Philosys has received an FDA 510(k) clearance for the Android version of its smart glucometer companion app, called Gmate Smart.