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Big Health Gets Good Night Sleep With FDA Approval Of Insomnia Digital Therapeutic

 
• By Marion Webb

Big Health announced it received FDA clearance for its digital therapeutics for insomnia and hopes a new CMS fee schedule will pave the way to reimbursement.

Insomnia
• Source: Shutterstock

Big Health announced on 8 August it has received US Food and Drug Administration clearance for its digital therapeutic (DTx), SleepioRx, for treating chronic insomnia as an adjunct to usual care for patients ages 18 and older.

Sleepio, a six-week digital program to help people improve quality of sleep, had already been recommended by the National Institute for Health and Excellence (NICE) as an effective alternative to sleeping pills in the UK and has been widely available at no cost to all residents in

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More from Policy & Regulation

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• By Brian Bossetta

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What’s A Diagnostic? WHO Wants To Know

 
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