FDA clears Big Health’s digital insomnia therapeutic

Big Health has secured FDA clearance for its flagship digital therapeutic, SleepioRx, as an adjunct treatment for chronic insomnia.

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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.”

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