FDA

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.

A study last year found that many people reported adverse drug events on Twitter.

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.

FDA clearances for digital health devices are on track to triple by 2018, according to new research from Accenture, as digital health offerings drive more than $100 billion in savings over that same time period.

New York City-based Cohero Health has received FDA 510(k) clearance for its mobile connected spirometer.

In the last two months, the FDA has cleared a number of clinically-focused mobile health devices.

An FDA-cleared clinical grade activity tracking system has come to the US for use in workplace injury prevention.

Intelesens's Zensor device.

A brain training game fined by the FTC earlier this year.