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FDA

By Jonah Comstock | 08:52 am | July 31, 2015
The US Department of Defense may soon start using smartphone-based diagnosis tools to detect traumatic brain injuries in soldiers on the battlefield.
By Jonah Comstock | 10:10 am | July 16, 2015
MedWatcher, a tool for adverse event reporting, that the FDA worked on with Epidemico.
By Jonah Comstock | 10:34 am | July 06, 2015
According to an SEC filing, mail-order personal genome service and research company 23andMe has raised $79 million, in a round the company hopes will top out at $150 million.
By Jonah Comstock | 09:03 am | July 06, 2015
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.
By Jonah Comstock | 08:19 am | June 25, 2015
An oral appliance for treating sleep apnea, with an embedded wireless compliance sensor, has received FDA clearance.
By Jonah Comstock | 09:00 pm | June 14, 2015
A study last year found that many people reported adverse drug events on Twitter.
By Jonah Comstock | 08:44 am | June 05, 2015
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.
By Jonah Comstock | 09:57 am | June 04, 2015
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.
By Jonah Comstock | 10:59 am | June 02, 2015
New York City-based Cohero Health has received FDA 510(k) clearance for its mobile connected spirometer.
By Jonah Comstock | 12:03 pm | May 27, 2015
In the last two months, the FDA has cleared a number of clinically-focused mobile health devices.