Certified Health Apps

All apps · Sleep & breathing

Certified sleep and breathing apps and devices

48 sleep and breathing apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.

39FDA verified
2CE class IIa or higher
3German DiGA
3no matching FDA record

Sleep apnea testing has moved to the home. Wearables, rings, patches and even smartwatch features are now cleared to help detect sleep apnea, and implanted and daytime therapies offer alternatives to the CPAP mask. For insomnia, Germany reimburses digital cognitive behavioural therapy.

Below you find every sleep and breathing tool we track, grouped by what we could verify in the official registers.

Digital sleep and respiratory care: the certified landscape 2026
Our sleep and respiratory care landscape for pharma, payers and hospitals: 4 segments, 48 tools, with an auditable verification level for every FDA entry. See the report · Free sample
Guide: digital sleep apnea management, 10 certified solutions See guides and reports

In the US: FDA verified (39)

Authorised by the FDA (510(k), De Novo or PMA), newest decisions first.

In the EU: CE class IIa or higher (2)

Found in EUDAMED as class IIa or higher. We show whether a notified body certificate is visible there.

In Germany: DiGA (3)

Listed in the German directory of reimbursed digital health applications.

CE class I (self-declared) (1)

Self-declared by the maker, without review by a notified body. We list these apart.

Watchlist (3)

These products are presented as certified, by their maker or in earlier directories, but we found no matching record in the official register, or they are no longer supported by their maker. Some are registered and listed with the FDA as exempt devices, which is legal but is not a clearance.

The trap to avoid

Sleep tracking is not sleep testing. Most sleep scores on watches and rings are wellness features. Only a device cleared for sleep apnea testing or detection supports a diagnosis, and even then a clinician makes the diagnosis.

Questions

Can a smartwatch detect sleep apnea?

Some features are cleared for that. In our directory, the Samsung Sleep Apnea Feature holds a 510(k). Such features flag possible sleep apnea; a diagnosis still needs a sleep test and a clinician.

Which home sleep apnea tests are FDA cleared?

In our directory, among others: Sunrise, Onera, TipTraQ, SANSA and Sleepiz One+, all with 510(k) decisions from 2025 or 2026. Wesper holds a 510(k) from 2021.

Is there an alternative to CPAP?

Inspire, an implanted nerve stimulator, is approved through the PMA route. ExciteOSA, a daytime tongue muscle stimulator, is authorised through the De Novo route. Both are prescribed by a specialist.

Are insomnia apps reimbursed in Germany?

Yes. somnio, HelloBetter Schlafen and somnovia are listed as DiGA for insomnia.

Certification status changes. Always confirm in the official register before relying on it. Not medical advice.

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