Full Breakdown
Apple and Samsung Smartwatches Gain FDA Clearance for Sleep Apnea Screening
6/26/2026, 11:53:44 AM
Regulatory Approvals for Wearable Sleep Apnea Detection
In 2024, Samsung received De Novo authorization from the U.S. Food and Drug Administration (FDA) for the Sleep Apnea feature built into its flagship smartwatch. Several months later, Apple secured FDA clearance through the 510(k) pathway for its own sleep-apnea notification capability. Both clearances allow the devices to screen users for patterns that may indicate sleep-disordered breathing and to prompt medical follow-up.
Understanding Sleep Apnea and Traditional Diagnosis
Sleep apnea is a disorder in which breathing repeatedly stops or is disrupted during sleep. Each episode typically lasts at least 10 seconds and can occur dozens of times per hour. The condition carries health risks and often disturbs both the patient and their partner through snoring, gasping, or restless movements. Definitive diagnosis traditionally requires an overnight study in a sleep laboratory, where patients are connected to multiple sensors and wires to monitor respiratory events.
Apple and Samsung: The Only Major Smartwatch Makers with FDA-Authorized Screening
Among the leading smartwatch manufacturers, only Apple and Samsung currently offer features that have received any form of FDA endorsement for sleep-apnea screening. No other major brand is reported to have secured comparable regulatory clearance for this specific function.
Timeline of FDA Actions
Key Figures & Groups Involved
- Apple Inc. – Developer of the iPhone-compatible smartwatch with an FDA-cleared sleep-apnea notification.
- Samsung Electronics – Producer of the smartwatch whose Sleep Apnea feature earned De Novo authorization.
- U.S. Food and Drug Administration – Federal agency that evaluated and authorized the two features under distinct regulatory pathways.
Data & Statistics Relevant to the Feature
Why It Matters: Potential Impact on Early Detection and Care
The FDA clearances enable consumers to receive preliminary alerts about possible sleep-apnea events directly from a device they already wear. Early identification can motivate users to seek professional evaluation, potentially reducing the time between symptom onset and formal diagnosis. Moreover, the convenience of continuous, at-home monitoring may lessen the reliance on overnight sleep-lab studies for initial screening, while also addressing partner-related sleep disturbances by highlighting underlying breathing irregularities.
Official Statements from Regulators and Companies
FDA documentation confirms that Samsung’s feature met the criteria for De Novo classification in 2024, indicating a novel device with a reasonable assurance of safety and effectiveness. Apple’s subsequent 510(k) clearance reflects the agency’s determination that the company’s notification system is substantially equivalent to an already legally marketed device. Both companies have indicated that the clearances are intended to supplement, not replace, clinical diagnosis and that users should consult healthcare professionals for definitive assessment.
