Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

by Samsung Electronics Co.  · Based in South Korea → — Proactive Heart Health Monitoring, Right from Your Wrist.
Cardiology Internal Medicine Sleep Medicine
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Included with compatible samsung galaxy watch and phone purchase
Regulatory Status Disclosed

Overview

The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (IHRN) is a mobile medical application integrated within the Samsung Health Monitor app. Operating on compatible Samsung Galaxy Watches and paired Galaxy Phones, it is designed for informational use in adults 22 years and older. The app proactively monitors heart rhythms in the background, analyzing pulse rate data to identify episodes suggestive of atrial fibrillation (AFib). Upon detection of irregular rhythms, it provides a notification, prompting the user to take an on-demand Electrocardiogram (ECG) for a more accurate measurement. The app records, stores, transfers, and displays single-channel ECGs, classifying traces as either AFib or sinus rhythm to aid in heart rhythm identification. Users can generate PDF reports of their ECG recordings to share with healthcare providers, facilitating discussions about their heart health.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Irregular Heart Rhythm Notification (IHRN) for AFib detection
  • On-demand Electrocardiogram (ECG) recording
  • Background heart rhythm monitoring
  • Classification of ECG traces (AFib or Sinus Rhythm)
  • PDF report generation for sharing with healthcare providers
  • Integration with Samsung Health Monitor app
  • Heart rate monitoring
  • Sleep apnea detection (on compatible Galaxy Watch models)
  • Blood pressure monitoring (requires calibration with cuff, not for medical use in US)

Use Cases

  • Personal heart health monitoring for adults 22+
  • Early detection of potential atrial fibrillation (AFib)
  • Tracking and recording heart rhythm data
  • Sharing heart health insights with healthcare professionals
  • General wellness and fitness tracking
  • Complementary tool for cardiovascular health awareness

What Physicians Need to Know

ECG/EKG Analysis Capability
The application records a single-channel electrocardiogram (ECG), similar to a Lead I ECG, to determine heart rhythm and rate. It classifies traces as either Atrial Fibrillation (AFib) or sinus rhythm.
Arrhythmia Detection Accuracy
The Irregular Heart Rhythm Notification (IHRN) feature analyzes pulse rate data in the background to identify episodes of irregular heart rhythms suggestive of AFib. It has received FDA clearance for AFib detection. Studies indicate high accuracy, with one pooled analysis reporting 100% sensitivity and 95% specificity for AFib detection, and Samsung devices yielding 97% sensitivity and 96% specificity in another meta-analysis. The ECG function accurately classified AFib recordings with a sensitivity of 96.0% and sinus rhythm recordings with a specificity of 98.7%.
Cardiac Monitoring Integration
The Samsung ECG Monitor Application functions as a companion app for compatible Samsung Galaxy Watches and Phones. ECG results automatically sync to the Samsung Health Monitor app on the paired phone, where data can be viewed, saved, and shared as a PDF with healthcare professionals. It requires pairing the Galaxy Watch and Galaxy Phone via Bluetooth and the Galaxy Wearable app.
Real-Time Alert Capability
The application provides notifications for irregular heart rhythms suggestive of AFib. If a certain number of consecutive measurements are irregular, the Galaxy Watch alerts the user to potential AFib activity, prompting them to take an on-demand ECG for a more accurate measurement. The IHRN feature checks for irregular heart rhythms in the background when the user is still and notifies if an irregular rhythm suggestive of AFib is detected for at least one hour.
Physician Tip

Physicians should advise patients that the Samsung ECG Monitor Application is for informational purposes only and is not a diagnostic tool. Patients should not interpret or take clinical action based on the device's output without consulting a qualified healthcare professional. It is crucial to emphasize that the app is designed to detect Atrial Fibrillation (AFib) but does not identify other arrhythmias or cardiac conditions such as heart attacks, heart failure, or blood clots. Patients should be encouraged to share the generated PDF reports of their ECG results for clinical review. It's also important to note that the Irregular Heart Rhythm Notification (IHRN) may not detect every instance of AFib, and the absence of a notification does not necessarily indicate the absence of a cardiac condition. The app is not intended for users under 22 years old or those with known arrhythmias other than AFib.

The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is exclusively compatible with specific Samsung Galaxy Watches (e.g., Galaxy Watch Active2, Watch3, and later models) and Samsung Galaxy Phones running Android OS 9.0 or later. It integrates with the Samsung Health Monitor app and the Galaxy Wearable app for setup, data synchronization, and management. The application is not available on non-Samsung Android devices or iOS devices. Its functionality is also restricted to countries where the Samsung Health Monitor has received regulatory approval.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Included with compatible samsung galaxy watch and phone purchase
  • No separate subscription fee for the application; functionality tied to compatible Samsung Galaxy Watch and Phone hardware
DeploymentMobile application (on compatible Samsung Galaxy Watch and paired Galaxy Phone)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Irregular Heart Rhythm Notification (IHRN) feature received FDA clearance in May 2023. The existing on-demand Electrocardiogram (ECG) function also has FDA clearance. The app is an over-the-counter (OTC) software-only, mobile medical application for informational use in adults 22 years and older, not intended to replace traditional diagnosis or treatment by a qualified healthcare professional.
Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Sleep Medicine

What the Web Says

The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification generally receives positive to mixed reviews, particularly for its accessibility and integration with Samsung's ecosystem. Physicians appreciate its potential for early detection of certain cardiac events, while tech reviewers highlight its user-friendliness. However, concerns exist regarding its diagnostic limitations and the need for professional medical interpretation.

Overall: Mixed

Strengths

  • Convenient and accessible for at-home monitoring.
  • Integration with Samsung Galaxy Watch and Health app.
  • Irregular heart rhythm notification can prompt users to seek medical attention.
  • User-friendly interface for recording and viewing ECGs.
  • Potential for early detection of Atrial Fibrillation (AFib).
  • Data can be easily shared with healthcare providers.

Limitations

  • Not a diagnostic tool; results require professional interpretation.
  • Potential for false positives or negatives, causing unnecessary anxiety or false reassurance.
  • Limited to detecting AFib and cannot diagnose other cardiac conditions.
  • Accuracy can be affected by user error or poor signal quality.
  • Requires a compatible Samsung Galaxy Watch and smartphone.
  • Some users may find the data overwhelming without medical guidance.

Based on reviews from: Samsung.com, Reddit (various subreddits), Healthcare IT News (general discussions on wearables), TechRadar, Android Authority, Digital Trends

Last updated: 2026-07-19

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Press & Coverage

Samsung Newsroom
The Future of Healthcare Fits on Your Wrist - Samsung Newsroom
This article discusses the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification as an over-the-counter, software-only mobile medical application for adults 22 and older, analyzing pulse rate data for AFib and suggesting ECG recordings. It also highlights the broader role of AI and wearables in healthcare and behavioral change.
2024-04
Samsung (Support Page)
Samsung ECG Monitor App with Irregular Heart Rhythm Notification
This support page details the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification, an OTC software-only mobile medical application for compatible Galaxy Watches and Phones, intended for informational use in adults 22 years and older to identify irregular heart rhythms suggestive of AFib. It also provides information on its validation and limitations.
unknown
Samsung Newsroom
Samsung Galaxy Ring, Watch7, Ultra Give More Health Insights
This press release announces the new Galaxy Ring, Galaxy Watch7, and Galaxy Watch Ultra, expanding Galaxy AI to enhance digital health. It mentions the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification as a feature for detecting irregular heart rhythms suggestive of AFib.
2024-07
FDA
510(k) Premarket Notification - FDA
This FDA premarket notification document details the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification as a software as a medical device (SaMD). It outlines its intended use for adults 22 and older to identify irregular heart rhythms suggestive of AFib and provides a notification to record an ECG.
2023-05
Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List - Orthogonal
This list of FDA-cleared Software as a Medical Devices (SaMD) includes the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification, cleared on May 2, 2023, for cardiovascular use.
2024-10
Samsung (Support Document)
SAMSUNG ECG Monitor App with Irregular Heart Rhythm Notification Instructions
This instruction manual provides details on the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification, an OTC software-only mobile medical application for compatible Samsung Galaxy Watch and Phone, for informational use in adults 22 years and older. It explains how the app analyzes pulse rate data to identify irregular heart rhythms suggestive of AFib.
2023-12
Verily Blog
Verily and Samsung Collaborate to Accelerate Clinical Research with the Galaxy Watch and Pre Platform
This article announces a collaboration between Verily and Samsung to accelerate clinical research using the Galaxy Watch. It highlights that Samsung has received FDA clearance for features including irregular heart rhythm notification, making the Galaxy Watch a robust research tool.
2026-03
Android (Google)
Health & Fitness Tracking Features for Your Smartwatch - Android
This article on Android's health and fitness tracking features for smartwatches mentions the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification. It describes it as an OTC software-only mobile medical application for adults 22 and older, designed to analyze pulse rate data for irregular heart rhythms suggestive of AFib.
2023-12

Videos

Product demos, reviews, and walkthroughs for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification.

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Frequently Asked Questions

Yes, the Irregular Heart Rhythm Notification (IHRN) feature of the Samsung Health Monitor app has received FDA clearance, as has the on-demand Electrocardiogram (ECG) function. It is classified as an over-the-counter (OTC) software-only, mobile medical application intended for informational use in adults 22 years and older.
The IHRN feature proactively monitors heart rhythms suggestive of atrial fibrillation (AFib) in the background using the Galaxy Watch's BioActive Sensor. If a pattern of irregular rhythms is detected, it notifies the user to take an on-demand ECG for a more accurate reading, which can then be shared with their healthcare provider.
The app is not intended for users with known arrhythmias other than AFib or those under 22 years old, and users should not take clinical action without consulting a healthcare professional. Clinical trials indicated that 16.8% of recordings could be inconclusive or poor, and the feature does not guarantee detection of every AFib episode.
The current irregular rhythm detection relies on algorithms to analyze pulse rate data for AFib. Samsung is exploring advanced AI, including generative AI models, to translate PPG signals into continuous ECG waveforms for future wearables, though they acknowledge the potential for 'fake information' affecting detection results.
The Samsung ECG app is comparable to features found in other FDA-cleared smartwatches like Apple Watch and Fitbit for irregular rhythm notifications and on-demand ECGs. Alternative portable devices like AliveCor KardiaMobile offer multi-lead ECGs and are also FDA-cleared, providing different form factors and monitoring approaches.
The Samsung ECG Monitor Application is a consumer-facing feature of Galaxy smartwatches, and specific pricing models for direct physician or healthcare system integration are not publicly available. Patients typically purchase the compatible Galaxy Watch and can share PDF reports of their ECG recordings with their healthcare providers via the Samsung Health Monitor app.

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