Breakthrough Device Designation Archives -

Digital health company Pear Therapeutics has won FDA breakthrough device status for reSET-A, its development-stage prescription digital therapeutic

Pear claims breakthrough tag for alcohol use disorder DTx

https://pharmaphorum.com/news/pear-claims-breakthrough-tag-for-alcohol-use-disorder-dtx/

A digital therapeutic for patients with heart failure has been awarded breakthrough device status by the FDA –

FDA gives breakthrough status to Biofourmis’ heart failure DTx

https://pharmaphorum.com/news/fda-gives-breakthrough-status-to-biofourmis-heart-failure-dtx/

The FDA’s drive to accelerate access to new medical device technologies continues, with a new product from 3i

FDA Breakthrough Device Designation for blood infection test

https://pharmaphorum.com/news/fda-breakthrough-device-designation-blood-infection-test/

Breakthrough Device Designation