Apple Watch secures FDA approval for sleep apnea detection

The US Food and Drug Administration (FDA) has granted its approval to the sleep apnea detection feature on the Apple Watch. The Apple Watch Series 10 and 9, as well as the Apple Watch Ultra 2, will now be able to detect and alert adults about the condition.

Apple gets FDA approval for sleep apnea detection on Apple Watch

The US FDA has been approving quite a few Apple products as over-the-counter (OTC) medical devices. Recently, the company’s AirPods 2 Pro secured FDA approval as OTC hearing aids.

The second-gen AirPods Pro can successfully replicate the functions of hearing aids. Similarly, multiple smartwatches from Apple can now be used to detect sleep apnea.

Samsung has also added this feature to its Galaxy Watch devices. The South Korean giant received FDA approval for sleep apnea detection in the US. In July, some Galaxy Watch users received sleep apnea detection as part of the One UI Watch 6 beta.

How does sleep apnea detection work on Apple Watch?

Apple had recently indicated that certain Apple Watches will get sleep apnea detection. Now that the US FDA has granted its approval, the company may actively advertise this function.

Apple has reportedly confirmed the sleep apnea detection feature uses the Apple Watch’s accelerometer to “monitor small movements at the wrist that are associated with interruptions in normal respiratory patterns”. If these disturbances occur frequently over multiple nights, they could be an indicator of sleep apnea.

Eligible Apple Watches will classify these disturbances as “elevated” or “not elevated”. Users can view the log, called “nightly Breathing Disturbances”, in the Health app on their iPhone.

Apple claims it developed the feature using “advanced machine learning”, which relied on an “extensive data set of clinical-grade sleep apnea tests”. Moreover, the company validated the feature’s capabilities in a “clinical study.”

Apple has, however, cautioned the feature, “is intended to detect signs of moderate to severe sleep apnea for people 18 years old or older who have not already been diagnosed with sleep apnea.” In other words, users should not consider the Apple Watch as a replacement for professional-grade medical devices used for diagnosis and treatment.