Pre-Cert program

By Dave Muoio 03:59 pm July 22, 2019
Prescription digital therapeutics company Pear Therapeutics announced late last week that it has filed an FDA marketing authorization for Somryst, its digital cognitive behavioral therapy for the treatment of adults with chronic insomnia and depression. While an approval from the agency would mark the third authorized prescription digital therapeutic for Pear — behind reSET for substance use...
By Laura Lovett 03:28 pm March 28, 2019
Within the last few years the FDA has undergone a metamorphosis when it comes to digital health regulations. Though many of these are not yet solidified, a recent report by PricewaterhouseCoopers (PwC) predicts that these changes could open new doors for pharmaceutical companies looking to jump into the digital arena.  “Changes made by the FDA have made it easier for digital health products to be...
By Dave Muoio 02:39 pm December 21, 2018
The last few months of 2018 have been fairly active for digital health regulation, with the US FDA roughly a dozen noteworthy devices and consumer health products. But the bigger news out of the agency this quarter comes in the form of its market guidance. For instance, the very beginning of October saw the release of the Medical Device Cybersecurity Regional Incident Preparedness and Response...