Skip to main content

FDA

By Jonah Comstock | 10:20 am | April 30, 2015
An FDA-cleared clinical grade activity tracking system has come to the US for use in workplace injury prevention.
By Jonah Comstock | 09:13 am | April 15, 2015
Intelesens's Zensor device.
By Jonah Comstock | 01:44 pm | April 13, 2015
A brain training game fined by the FTC earlier this year.
By Jonah Comstock | 11:05 am | April 01, 2015
Sense4Baby, the maternal and fetal monitoring product developed by West Health and then acquired by AirStrip Technologies, has received a second FDA 510(k) clearance, which will allow pregnant mothers to perform non-stress tests in their homes.
By Jonah Comstock | 12:07 pm | March 25, 2015
Vital Art and Science, developers of myVisionTrack, a vision test service for patients with age-related macular degeneration or diabetic eye disease, has received a second FDA clearance for their platform, which includes an app and a provider dashboard.
By Jonah Comstock | 09:24 am | January 28, 2015
The Dexcom G4 receiver, which will have an "identical" form factor to the forthcoming Bluetooth version.
By Jonah Comstock | 09:56 am | January 26, 2015
The old Dexcom Share, with charging cradle.
By Jonah Comstock | 01:36 pm | January 20, 2015
Days after the FDA issued new draft guidance that may be softer on devices making certain kinds of medical claims, the FTC has reminded companies that it also has regulatory power over health claims and might be stepping up to the plate.
By Jonah Comstock | 08:46 am | December 02, 2014
Google-backed 23andMe is finally relaunching its mail-order personal genome service -- just not in the United States.
By Jonah Comstock | 10:24 am | December 01, 2014
Bradley Merrill Thompson testifying before Congress last year.