FDA 510(k)

Israeli company seeks FDA nod for ear-clip-based glucose monitoring
By Jonah Comstock | 09:51 am | August 17, 2015
Roche launches FDA-cleared diabetes app with insulin calculator in US
By Jonah Comstock | 12:28 pm | July 08, 2015
Theranos gets unnecessary FDA clearance for its cheap, fingerstick blood tests
By Jonah Comstock | 09:03 am | July 06, 2015
Sleep apnea treatment device with wireless compliance sensor gets FDA nod
By Jonah Comstock | 08:19 am | June 25, 2015
FDA clears smartphone-connected pelvic floor muscle training device for incontinence
By Aditi Pai | 12:09 pm | June 17, 2015
Medtronic partners with Samsung on mobile diabetes, gets major FDA nod
By Jonah Comstock | 08:44 am | June 05, 2015
App-based vision test gets second FDA clearance, remote trial with Scripps, Roche
By Jonah Comstock | 12:07 pm | March 25, 2015
AliveCor ECG gets FDA clearance for two more algorithms
By Jonah Comstock | 05:02 am | January 29, 2015
LG receives FDA clearance, likely for a mobile health app
By Jonah Comstock | 10:15 am | December 01, 2014
FDA clears Qardio's sleek, connected blood pressure device
By Aditi Pai | 11:09 am | June 20, 2014