In an FDA first, Boston- and San Francisco-based Pear Therapeutics' reSET system for the treatment of substance abuse has been granted a de novo clearance by the agency. It's the first software-only digital therapeutic the FDA has cleared with claims to improve clinical outcomes in a disease.

“This is a defining moment for digital therapeutics and for patients with substance use disorder,” Corey McCann, president and CEO of Pear Therapeutics said in a statement. “As the first FDA-cleared Prescription Digital Therapeutic for disease treatment, reSET has demonstrated improved abstinence and treatment retention in a randomized controlled clinical study. We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology, and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas. Pear was impressed by the collaborative approach the FDA took in reviewing this innovative technology.”

reSET is a 12-week program designed to treat addiction and dependency on stimulants, cannabis, cocaine, and alcohol. The system is not usable for opioids, but Pear is also seeking clearance for an opioid product called reSET-O. Interventions and assessment tools are provided to the patient via a mobile health, and the data collected is delivered to a clinician dashboard.

Pear Therapeutics has studied the software in a number of randomized trials. In one, compared to the control group, twice as many patients who used the software were abstinent after 9 and 12 weeks. 

“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health, said in a statement. “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”

De novo clearances are used for novel devices of low- to moderate-risk. They're more onerous than traditional 510(k)s, but once one device in a class has one, subsequent similar devices can be cleared more easily.