FDA

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.

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.

The Dexcom G4 receiver, which will have an "identical" form factor to the forthcoming Bluetooth version.

The old Dexcom Share, with charging cradle.

Days after the FDA issued new draft guidance that may be softer on devices making certain kinds of medical claims, the FTC has reminded companies that it also has regulatory power over health claims and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.

Google-backed 23andMe is finally relaunching its mail-order personal genome service -- just not in the United States.

Bradley Merrill Thompson testifying before Congress last year.

South Korean technology company LG Electronics has received an FDA 510(k) clearance for something called "LG Smarthealth".

Dexcom Share, a cradle device that will allow users to send data from a Dexcom continuous glucose monitor to multiple smartphones, has received 510(k) clearance from the FDA.

Urine analysis app uChek is about to launch a six-month, 375-patient trial with Merck for Mothers, a Merck-sponsored initiative to reduce global maternal mortality, according to ClinicalTrials[dot]gov.