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Smartwatch Sleep Apnea Alerts Get FDA Authorisation

Quick answer

Two major smartwatch makers now have FDA-authorised sleep apnea notification features. They flag signs of possible obstructive sleep apnea; they do not diagnose it.

News Development: February 2024 · Published 2026-10-31 · By Sleepwit Sleep Team

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Key points

  • What was authorised. Samsung announced that the US FDA granted De Novo authorisation to a sleep apnea feature on Galaxy Watch on 6 February 2024.
  • How it works. The features use the watch's sensors over several nights to look for breathing disturbances.
  • Limits. A notification is a prompt to seek a medical assessment.
  • What it means for you. If a watch flags possible sleep apnea, or if you snore loudly with pauses in breathing or feel very sleepy in the day, speak to a doctor.
  • More from the news desk. News · Sleep technology CES 2026 Sleep Tech A reading of the sleep technology shown at CES 2026, from smart beds and rings to radar sensors and EEG headbands, with evidence caveats.

What was authorised

Samsung announced that the US FDA granted De Novo authorisation to a sleep apnea feature on Galaxy Watch on 6 February 2024. Reports describe it as intended to detect signs of moderate to severe obstructive sleep apnea in adults aged 22 and over who have not been diagnosed, and not as a replacement for clinical diagnosis. Apple's feature was cleared through the FDA 510(k) route, according to Engadget; the sources we found do not give a consistent date or model list for Apple, so check Apple's own pages.

How it works

The features use the watch's sensors over several nights to look for breathing disturbances. Samsung's feature needs two nights of tracking within a ten-day period, per reports.

Limits

A notification is a prompt to seek a medical assessment. It cannot grade severity, and it does not replace a sleep study. Availability varies by country, and Australia has been reported to have approved Apple and Samsung sleep apnoea technology.

What it means for you

If a watch flags possible sleep apnea, or if you snore loudly with pauses in breathing or feel very sleepy in the day, speak to a doctor. A mattress or pillow cannot treat sleep apnea; see our guide on warning signs.

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Sources

  1. Samsung press release: sleep apnea feature authorised by US FDA Source
  2. MedTech Dive: Samsung FDA watch sleep apnea Source
  3. Engadget: Can your smartwatch detect sleep apnea? Source

Links were checked when this post was written. Pages change; check the original for the current wording. Where sources are secondary coverage, the post says so.

More from the news desk

General information, not medical advice. Speak to a doctor about symptoms or medical devices.

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