FDA approves sleep apnea detection for Apple Watch models

On Monday, the U.S. Food and Drug Administration (FDA) approved a new sleep apnea detection feature on the Apple Watch Series 9, Series 10, and Watch Ultra 2. This approval comes just four days before the highly anticipated release of the Series 10 on September 20. The sleep apnea detection feature, introduced at the recent iPhone 16 event, will be included in the upcoming watchOS 11 releases.

This new feature, designed to assess the risk of sleep apnea, requires users to track their sleep over 30 days, collecting data for a minimum of 10 nights. The feature will analyze this data to identify potential symptoms of sleep apnea and provide insights into sleep disturbances. While it is classified by the FDA as an “over-the-counter device,” it is important to note that the Apple Watch’s sleep apnea detection is not intended to serve as a diagnostic tool. Instead, it will alert users to seek a formal diagnosis from a healthcare provider if risk factors are detected.

Sleep apnea is a condition characterized by intermittent breathing interruptions during sleep, which can lead to various symptoms including insomnia, headaches, daytime sleepiness, and other long-term health issues. This feature aims to assist users in recognizing potential signs of the condition, prompting them to consult a medical professional for a comprehensive evaluation.

In addition to this new feature, Apple Watch users in the U.S. will note that the previously available blood oxygen detection has been disabled due to an ongoing patent dispute. Despite this setback, the approval of the sleep apnea detection feature marks a significant advancement in wearable health technology.