Digital health company Pear Therapeutics has won FDA breakthrough device status for reSET-A, its development-stage prescription digital therapeutic (DTx) for people with alcohol-use disorde
A digital therapeutic for patients with heart failure has been awarded breakthrough device status by the FDA – said by its developer Biofourmis to be the first time the US regulator h
The FDA’s drive to accelerate access to new medical device technologies continues, with a new product from 3i Diagnostics receiving a Breakthrough Device Designation.