FDA

ImPACT gets de novo FDA clearance for concussion assessment apps
By Jonah Comstock | 03:23 pm | August 23, 2016
Senseonics shows accuracy in US trial as it gears up for FDA submission
By Jonah Comstock | 02:39 pm | August 10, 2016
Recent FDA guidances cover software changes, real world evidence, wellness devices
By Jonah Comstock | 05:12 pm | August 09, 2016
Product recall dings Dexcom's Q2, but hopes are high after FDA panel greenlight
By Jonah Comstock | 02:30 pm | August 03, 2016
Lilly-backed smartphone-enabled insulin pen gets FDA nod
By Jonah Comstock | 03:38 pm | July 28, 2016
Intellirod Spine raises $1M to add wireless sensors to spine implants
By Jonah Comstock | 04:50 pm | July 27, 2016
FDA panel advises agency to greenlight Dexcom G5 CGM as replacement to fingerstick treatment decisions
By Heather Mack | 01:35 pm | July 22, 2016
Round-up: FDA clearances so far in 2016
By Heather Mack | 08:06 pm | July 21, 2016
Nokia Technology gets FDA clearance for Withings Thermo, a WiFi-enabled thermometer
By Jonah Comstock | 03:40 pm | June 29, 2016
FDA declines to approve Proteus-Otsuka sensor-equipped pill, asks for more tests
By Jonah Comstock | 03:01 pm | April 27, 2016