All apps · Sleep & breathing

Is Sleepio FDA approved or cleared?

Yes. Sleepio by Big Health, Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2024.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

At a glance

Product	Sleepio
Maker	Big Health, Inc.
Care area	Sleep & breathing
What it does	Digital therapeutic for chronic insomnia using cognitive behavioral therapy
FDA	510(k), latest decision 2024
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	bighealth.com
Status	FDA verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes

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