Big Health has secured FDA clearance for its flagship digital therapeutic, SleepioRx, as an adjunct treatment for chronic insomnia.
Designed for adults 18 and older, SleepioRx complements standard care by delivering cognitive behavioral therapy for insomnia via a prescription device. This 90-day treatment adapts to individual symptoms, offering daily sleep tracking and on-the-spot therapeutic content to assist with sleep.
"The FDA's clearance of SleepioRx is a landmark milestone for Big Health, providing accessible, guideline-recommended, first-line treatment for insomnia," Big Health CEO Yael Berman said in the Aug. 8 release. "This clearance, coupled with the new proposed reimbursement codes, will for the first time motivate U.S. healthcare providers to prescribe safe and effective treatment alternatives to traditional medication."