FDA 510(k)

A smart baby bottle, which uses sensors to measure a baby's tongue strength and sends the data to a provider's mobile device, has received FDA clearance.

Israeli medical device company Integrity Applications has begun the process with the FDA to bring its noninvasive glucose monitoring device, GlucoTrack, to the United States.

Last month, Roche quietly launched its Accu-Chek Connect app, a diabetes management app which contains, among other things, an unprecented feature: a prescription insulin bolus calculator called Bolus Advisor.

Theranos, the 12-year-old Palo Alto-based company working on a smaller, cheaper, alternative to common lab blood tests, has received its first voluntary FDA 510(k) clearance, for its herpes simplex 1 virus IgG (HSV IgG) test.

An oral appliance for treating sleep apnea, with an embedded wireless compliance sensor, has received FDA clearance.

Australia-based Analytica has received FDA 510(k) clearance for PeriCoach, its smartphone-connected device that helps women monitor their pelvic floor exercises.

Medtronic has received FDA 510(k) clearance for its MiniMed Connect device, which allows users of Medtronic's continuous glucose monitor (CGM) and insulin pump to view data from those devices on their smartphone.

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.

AliveCor's AF detection algorithm San Francisco-based AliveCor has received FDA clearance for two new algorithms for its smartphone-connected ECG: one that detects normality and one that detects interference.

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