FDA cleared apps

FDA-cleared surgery iPad app company Gauss raises $3.3M
By Brian Dolan | 07:42 am | August 24, 2015
Los Altos, California-based Gauss Surgical has raised $3.
FDA clears smartphone-connected pelvic floor muscle training device for incontinence
By Aditi Pai | 12:09 pm | June 17, 2015
Australia-based Analytica has received FDA 510(k) clearance for PeriCoach, its smartphone-connected device that helps women monitor their pelvic floor exercises.
FDA medical app regulation and the art of intended use
By MHN Staff | 08:03 am | April 13, 2015
By Bradley Merrill Thompson With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app.
FDA clears iPad app for pre-operative surgical planning
By Aditi Pai | 09:09 am | March 30, 2015
Israel-based Voyant Health, a subsidiary of Germany-based medical technology company Brainlab, received FDA clearance for its iPad app, called TraumaCad Mobile, which helps orthopedic surgeons with their pre-operative surgical planning.
App-based vision test gets second FDA clearance, remote trial with Scripps, Roche
By Jonah Comstock | 12:07 pm | March 25, 2015
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.
FDA clears iPad medical app for measuring surgical blood loss in canisters
By Aditi Pai | 10:00 am | March 17, 2015
Los Altos, California-based Gauss Surgical has received an FDA 510(k) clearance for its Triton iPad app, which can now estimate the surgical blood loss in canisters that hold blood.
FDA wellness clarifications helpful, accessory proposal is just a start
By Brian Dolan | 08:23 am | January 20, 2015
Bradley Merrill Thompson At the end of last week the FDA posted two draft guidance documents related to digital health.
Telcare raises $32.5 million for cellular-enabled glucose meter, to expand to related conditions
By Brian Dolan | 09:48 am | October 22, 2014
Bethesda, Maryland-based cellular-enabled blood glucose meter company Telcare has raised $32.
FDA clears military-tested PTSD, brain injury assessment app
By Brian Dolan | 07:17 am | October 20, 2014
Last week the FDA granted 510(k) clearance to a mobile-based cognitive test called DANA (Defense Automated Neurobehavioral Assessment), which helps healthcare providers better assess the medical or psychological state of their patients.
23 notable FDA clearances for digital health apps, devices so far this year
By Brian Dolan | 10:07 am | September 24, 2014
MobiHealthNews has been tracking FDA clearances for smartphone-connected medical devices and standalone apps for many years.