FDA

Visible Patient gets FDA clearance for custom 3D anatomy models, app still to come
By Jonah Comstock | 09:50 am | November 17, 2015
Visible Patient, a French company that makes 3D models of human organs to assist surgeons, has received FDA 510(k) clearance for its VP Planning Software Suite.
FDA seeks lessons learned from remote clinical drug trials
By Jonah Comstock | 10:42 am | November 04, 2015
Exco InTouch's mobile clinical trial software.
Two years after FDA letter, 23andMe finally relaunches consumer genetic testing in US
By Aditi Pai | 12:23 pm | October 22, 2015
Almost two years after the FDA first told 23andMe to halt sales on its mail-order direct-to-consumer genetic testing service for disease risks, the company has relaunched a version of its new Personal Genome Service (PGS), which now meets FDA standards.
NFANT Labs gets FDA nod for smart baby bottle sensors for the NICU
By Jonah Comstock | 12:04 pm | October 12, 2015
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.
How the FDA process is biased against new technology
By MHN Staff | 10:00 am | September 10, 2015
by Bradley Merrill Thompson Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea.
Israeli company seeks FDA nod for ear-clip-based glucose monitoring
By Jonah Comstock | 09:51 am | August 17, 2015
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.
PhysIQ receives FDA 510(k) clearance for physiology analytics engine
By Aditi Pai | 10:21 am | August 04, 2015
Naperville, Illinois-based PhysIQ has received an FDA 510(k) clearance for its personalized physiology analytics system.
DoD taps FDA-cleared device for battlefield diagnosis of traumatic brain injuries
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.
FDA, Google met to discuss use of search to find adverse drug reactions
By Jonah Comstock | 10:10 am | July 16, 2015
MedWatcher, a tool for adverse event reporting, that the FDA worked on with Epidemico.
23andMe raises $79 million as it shifts focus to research, drug development
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.