Sleep Apnea Feature

by Samsung Electronics Co.  · Based in South Korea → — Proactive detection of sleep apnea signs for a healthier tomorrow.
Otolaryngology (ENT) Pulmonology Sleep Medicine
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Free with compatible samsung galaxy watch and phone.
Regulatory Status Disclosed

Overview

The Samsung Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application available on compatible Samsung Galaxy Watches and phones, integrated within the Samsung Health Monitor app. It is designed to detect signs of moderate to severe obstructive sleep apnea (OSA) in adult users aged 22 and older who have not been previously diagnosed with the condition. The feature leverages the Galaxy Watch’s BioActive Sensor, utilizing PPG and actigraphy technology to monitor blood oxygen levels and identify significant breathing disruptions over a two-night monitoring period. The aim is to empower users to proactively identify potential signs of OSA and encourage them to seek professional medical consultation. It is crucial to note that this feature is not intended to replace traditional methods of diagnosis and treatment by a qualified clinician, nor is it designed to assist clinicians in diagnosing sleep disorders.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Detects signs of moderate to severe obstructive sleep apnea (OSA)
  • Utilizes Galaxy Watch's BioActive Sensor (PPG and actigraphy)
  • Requires two-night monitoring period (minimum 4 hours each night within 10 days)
  • Estimates Apnea-Hypopnea Index (AHI)
  • Integrated with Samsung Health Monitor app
  • Provides results to users for informed consultation with medical professionals
  • Over-the-counter (OTC) software-only mobile medical application

Use Cases

  • Proactive detection of potential sleep apnea signs by consumers
  • Empowering individuals to seek medical care for sleep-related concerns
  • Personal sleep health monitoring and awareness

What Physicians Need to Know

Sleep Apnea Detection
The Samsung Sleep Apnea Feature, an FDA-authorized software-only mobile medical application, detects signs of moderate-to-severe obstructive sleep apnea (OSA) in adults aged 22 and older. It utilizes the Galaxy Watch's BioActive Sensor to measure blood oxygen saturation (SpOu2082) during sleep, analyzing changes in SpOu2082 levels related to apnea and hypopnea patterns to estimate the Apnea-Hypopnea Index (AHI).
Mobile Notification System
After two nights of monitoring (at least 4 hours of sleep each night within a 10-day period), the feature provides results on the Samsung Health Monitor app on the connected phone, indicating whether signs of moderate-to-severe obstructive sleep apnea were detected. It then advises users to contact a healthcare professional for an evaluation.
Physician Tip

This tool is a pre-diagnosis or supplementary screening tool for obstructive sleep apnea and is not intended to replace traditional methods of diagnosis and treatment by a qualified clinician. It is not for users already diagnosed with sleep apnea. Physicians should advise patients that results from this feature are potential health markers, not definitive diagnoses, and should always be followed by professional medical consultation for comprehensive evaluation and management. Patients should not alter medication or treatment plans based solely on these results.

The Sleep Apnea Feature operates as a software-only application within the Samsung Health Monitor app. It requires a compatible Samsung Galaxy Watch (Galaxy Watch4 or newer, running Wear OS 5.0 or later) paired with a Samsung Galaxy phone (Android OS 9.0 or higher) to function. Data is viewed, saved, and shared via the Samsung Health Monitor app on the connected phone.

Details

Category Neurology AI, Wearables & Remote Monitoring (RPM)
Pricing Free with compatible samsung galaxy watch and phone. — N/A
DeploymentMobile application (on compatible Samsung Galaxy Watch and Phone)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Sleep Apnea Feature received De Novo authorization from the US FDA (DEN230041) on February 6, 2024, as an over-the-counter (OTC) software-only, mobile medical application intended to detect signs of moderate to severe obstructive sleep apnea in adults 22 years and older over a two-night monitoring period.
Integrations
EHR Not specified
Specialties Otolaryngology (ENT), Pulmonology, Sleep Medicine

What the Web Says

The Samsung Galaxy Watch's Sleep Apnea Feature is an FDA-cleared tool designed to detect signs of moderate to severe obstructive sleep apnea (OSA) in adults aged 22 and older who have not been previously diagnosed with the condition. It works by monitoring blood oxygen levels during sleep and requires at least two nights of sleep tracking (minimum four hours each) within a 10-day period to provide results. While not a diagnostic tool itself, it aims to encourage users to consult with a healthcare professional for further evaluation and potential treatment.

Overall: Positive

Strengths

  • FDA-cleared for detecting signs of moderate to severe obstructive sleep apnea.
  • Can lead to earlier detection of undiagnosed OSA, prompting users to seek medical advice.
  • Utilizes blood oxygen sensors to identify breathing disruptions during sleep.
  • Integrated with the Samsung Health Monitor app for comprehensive health tracking.
  • No mandatory monthly subscription fees for core metrics.
  • May help reduce complications associated with untreated sleep apnea.

Limitations

  • Not a diagnostic tool; results require follow-up with a doctor.
  • Does not detect central sleep apnea or mild cases of OSA.
  • Limited to users aged 22 and older who have no prior sleep apnea diagnosis.
  • Requires specific conditions for data collection (e.g., snug watch fit, sufficient sleep duration).
  • Some users on Reddit reported issues with the feature's availability or accuracy.
  • Blood pressure features require regular calibration with a standard cuff.

Based on reviews from: MedGrade, CNET, Trusted Reviews, Medthority, Reddit, TechRadar, YouTube

Last updated: 2026-07-18

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Press & Coverage

Samsung Global Newsroom
[World Sleep Day 2026] How Samsung Is Tackling Sleep Apnea to Energize Your Days
On World Sleep Day 2026, Samsung highlighted its Sleep Apnea feature on Galaxy Watch, which uses the BioActive Sensor to track blood oxygen levels and detect signs of moderate to severe obstructive sleep apnea. The feature is available in 78 markets worldwide after receiving De Novo authorization from the U.S. FDA.
2026-03
Samsung Global Newsroom
Samsung Expands Global Availability of Sleep Apnea Feature on Galaxy Watch Series
Samsung announced the expansion of its Sleep Apnea feature to 34 European markets, Australia, and Singapore, bringing the total to 70 markets globally. This follows CE marking for the European Economic Area and approvals from various health regulatory agencies worldwide.
2025-06
Fierce Biotech
Samsung scores FDA de novo nod for sleep apnea feature on Galaxy smartwatches
Samsung received De Novo authorization from the U.S. FDA for its smartwatch-based sleep apnea feature, making it the first of its kind to be authorized by the FDA. The feature, cleared in Korea previously, will be available to Galaxy Watch users in the U.S. in Q3 2024.
2024-02
BioWorld
FDA approves Samsung's sleep apnea feature on Galaxy watch, phone | BioWorld
The U.S. FDA approved Samsung's new feature for detecting obstructive sleep apnea (OSA) on the Galaxy Watch and smartphone, cleared as software as a medical device (SaMD). This marks Samsung's second approval after South Korea's MFDS nod in October 2023.
2024-02
Respiratory Therapy
Samsung Galaxy Watch's Sleep Apnea Feature Granted FDA De Novo Status
Samsung Electronics announced that its sleep apnea feature on the Samsung Health Monitor app received De Novo authorization from the US FDA, allowing it to detect signs of moderate to severe obstructive sleep apnea in users over 22 who haven't been diagnosed. The feature is intended for on-demand use and not as a replacement for traditional diagnosis.
2024-02
ZDNET
Your Galaxy Watch could get a major sleep apnea upgrade, thanks to AI and Stanford
Samsung announced a collaboration with Stanford Medicine to enhance its obstructive sleep apnea feature on the Galaxy Watch, aiming to move beyond detection to proactive management using AI. The feature, which received FDA De Novo classification, is available in 29 markets globally.
2025-04
accessdata.fda.gov
De Novo Classification Request for Sleep Apnea Feature - accessdata.fda.gov
This FDA De Novo summary details the Samsung Sleep Apnea Feature as an over-the-counter, software-only mobile medical application for compatible Galaxy Watches and phones. It leverages PPG and actigraphy to assess moderate-to-severe obstructive sleep apnea in adults over 22, requiring two successful nights of observation within 10 days.
2023-05
Samsung (Official Product Page)
Sleep Apnea Feature - Samsung
The Samsung Sleep Apnea feature is an over-the-counter, software-only mobile medical application on Galaxy Watches and phones, designed to detect signs of moderate-to-severe obstructive sleep apnea in adults over 22. It tracks blood oxygen levels and breathing disruptions over two nights of sleep to provide a risk assessment.
unknown

Videos

Product demos, reviews, and walkthroughs for Sleep Apnea Feature.

View all on YouTube

Frequently Asked Questions

AI features can integrate by assisting with screening, scoring sleep studies, and identifying high-risk patients, thereby streamlining the diagnostic process and reducing the need for manual analysis. These systems typically require inputs such as biosignals from sleep studies (e.g., EEG, ECG, airflow, oximetry), electronic medical record data, and patient-reported symptoms.
Regulatory clearance, such as FDA approval, is crucial for AI medical devices, with some AI sleep disorder diagnosis algorithms already receiving such clearances. To ensure HIPAA compliance, AI tools must implement technical, administrative, and contractual safeguards, including robust encryption of Protected Health Information (PHI) and Business Associate Agreements (BAAs) with vendors.
While PSG remains the gold standard, AI aims to overcome its limitations by offering faster, more accessible, and less labor-intensive diagnostic support. AI models for OSA detection have shown diagnostic accuracy ranging from 67% to 98.6%, with hybrid models often demonstrating high performance, though they typically serve as an aid rather than a replacement for a clinician's final diagnosis.
The cost of implementing AI in healthcare varies significantly, with diagnostic AI systems typically ranging from $200,000 to $800,000, depending on complexity and integration needs. Pricing models can include initial implementation fees, software licensing, and ongoing costs for maintenance, updates, and model retraining, which can add $1,000-$5,000 per month.
Key limitations include the potential for biases in the AI system if the training data is not large and representative of diverse patient populations, which can affect predictive accuracy. AI tools may also struggle with the nuanced terminology of specialized medicine and cannot fully replace a clinician's judgment or understanding of individual patient preferences and complex comorbidities.
The efficacy and reliability of AI features are supported by clinical evidence and peer-reviewed studies, which are essential for building trust and facilitating adoption among physicians. For instance, some FDA-approved AI algorithms for sleep disorder diagnosis have undergone clinical trials with hundreds of subjects to validate their performance.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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