MedPath

Apple Watch Receives FDA Clearance for Sleep Apnea Detection

• Apple's watchOS 11 has gained FDA approval for its sleep apnea detection feature, set to launch on Monday. • The feature monitors wrist movements during sleep to identify potential respiratory pattern interruptions, a key indicator of sleep apnea. • This approval follows similar clearances for sleep apnea detection in Samsung's Galaxy Watch and Apple's AirPods Pro as hearing aids, marking a growing trend of tech companies entering the health sector.

Apple has secured FDA clearance for its sleep apnea detection feature on the upcoming watchOS 11, signaling a significant advancement in consumer health technology. The feature, slated for release on Monday, will be available on Apple Watch Series 9, Ultra 2, and the forthcoming Series 10.
The sleep apnea detection system analyzes subtle wrist movements during sleep, identifying disturbances in normal breathing patterns. According to Apple, the technology is designed to monitor these movements monthly and alert users to potential signs of sleep apnea, providing data that can be shared with healthcare professionals for further evaluation.
"Small movements at the wrist during sleep that are associated with interruptions in normal respiratory patterns," are key indicators the device will monitor, the company stated. Disruptions to breathing while asleep are the main symptom of sleep apnea.
This FDA clearance follows a similar approval granted to Samsung for its Galaxy Watch sleep apnea detection feature earlier this year. Furthermore, the FDA recently approved Apple's AirPods Pro as an over-the-counter hearing aid device, highlighting the increasing convergence of technology and healthcare.
The move underscores a growing trend among tech giants to integrate health-monitoring capabilities into their devices, potentially impacting the diagnosis and management of various medical conditions. While pre-order data for the iPhone 16 disappointed analysts, Apple's continued push into health technology demonstrates a strategic diversification of its product offerings.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Reference News

[1]
Apple Gets FDA Approval for Smartwatch Sleep Apnea Detection Feature - Investopedia
investopedia.com · Sep 16, 2024

Apple received FDA approval for sleep apnea detection on watchOS 11, usable on Apple Watch Series 9, Ultra 2, and Series...

© Copyright 2025. All Rights Reserved by MedPath