FDA has approved marketing of Pear Therapeutics' Reset, a mobile medical app to help treat alcohol, cocaine, marijuana and stimulant substance use disorder (SUD), the agency announced Thursday (Sept. 14). The app, intended to be used with outpatient therapy, was reviewed through FDA's de novo pre-market review pathway for low- to moderate-risk devices. In approving the app, FDA reviewed data from an unblinded 12-week clinical trial that enrolled 399 patients and was conducted at multiple sites. “The data showed a...