PEAR Obtains FDA Clearance of the First Prescription Digital Therapeutic to Treat Disease

BOSTON, and SAN FRANCISCO, September 14, 2017– Pear Therapeutics, the leader in a new era of prescription digital therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Pear’s De Novo request, allowing the company to market reSET® for the treatment of patients with substance use disorder (SUD) under a new class of treatment. This is the first time that the FDA has cleared a Prescription Digital Therapeutic with claims to improve clinical outcomes in a disease.

“This is a defining moment for digital therapeutics and for patients with substance use disorder,” said Corey McCann, President and Chief Executive Officer of Pear Therapeutics. “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.”

Click here for the full PEAR Press Release…

Click here for the FDA Press Release…

Click here for the PEAR Therapeutics Media Kit…

 

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