Pear Therapeutics Obtains FDA Authorization For Its Insomnia Therapeutic

Pear Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has granted authorization for Somryst™, the first prescription digital therapeutic (PDT) intended for use in the treatment of individuals 22 years of age and older with chronic insomnia. Somryst is the first product submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed as part of FDA’s Software Precertification Pilot Program to help build and test FDA’s Digital Health Precertification Working Model 1.0.

Somryst is intended to provide tailored neurobehavioral interventions, specifically Cognitive Behavioral Therapy for insomnia (CBTi) and sleep restriction driven by algorithms . . .