A heavily studied mobile medical app intended to support treatment of opioid use disorder (OUD) is among the first 510(k)-route products to gain entry into US FDA's Breakthrough Devices Program, providing some insight into the types of products that might be considered breakthroughs even though they are seeking a "substantial equivalence" claim to something already on the market.
Pear Therapeutics announced Expedited Access Pathway designation earlier this month for its reSET-O Prescription Digital Therapeutic for OUD. FDA has...