Pre-Cert program

Pear Therapeutics' digital insomnia therapeutic will put FDA's PreCert framework through its paces
By Dave Muoio | 04:59 pm | July 22, 2019
CEO and President Dr. Corey McCann said that Somryst, a digital treatment for chronic insomnia and depression, is the first software as a medical device product to be submitted through the regulator's pilot pathway. 
FDA regulations could create digital health opportunities for pharma
By Laura Lovett | 04:28 pm | March 28, 2019
A new report from PwC predicts that new and proposed FDA regulations could open up doors for pharmaceutical companies looking to develop digital tools. 
New market guidances, regulatory pathway change proposals close out 2018 for FDA
By Dave Muoio | 03:39 pm | December 21, 2018
The regulatory changes also come alongside Pre-Cert Program updates and roughly a dozen noteworthy digital health approvals.