FDA Finally Authorizes Samsung’s Sleep Apnea Feature

Samsung recently announced that the US Food and Drug Administration (FDA) has finally granted “de novo” authorization for the company’s sleep apnea feature (which is accessible via the Samsung Health App), Samsung announced on Saturday.

The feature lets users over 22 years old detect signs of moderate to severe sleep apnea to allow for a possible diagnosis. This works over a two-night monitoring period, and users can track their sleep twice for more than four hours within a ten-day period. Earlier on, the sleep apnea feature was granted authorization by Korea’s Ministry of Food and Drug Safety (MFDS) back in October.

Samsung does include a disclaimer though, stating that the feature “is not intended for users who have previously been diagnosed with sleep apnea.”

With that said though, the feature won’t be widely-available for all users – Samsung states that the sleep apnea feature will be available for select Galaxy Watch device in North America later in Q3 2024, and will be accessible via the Samsung Health Monitor app. There’s no word yet if any more countries or markets will receive the feature.

READ: Samsung could be refreshing the Galaxy Watch 4 this year, and we don’t know why

Source: Samsung

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