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# Samsung Irregular Heart Monitor on Watch Cleared
- URL: https://www.fdaweb.com/samsung-irregular-heart-monitor-on-watch-cleared/
- Published: 2023-05-08T12:00:00.000Z
- Updated: 2026-09-14T18:30:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154391

FDA has cleared a Samsung Electronics 510(k) for its Irregular Heart Rhythm Notification (IHRN) feature on its Health Monitor app for Samsung Galaxy watches. “Together with the app’s existing on-demand Electrocardiogram (ECG) function, the IHRN feature proactively monitors heart rhythms suggestive of atrial fibrillation (AFib), right from their wrist,” the company says.

“Once activated in the Samsung Health Monitor app, the feature will check for irregular heart rhythms in the background via Galaxy Watch’s BioActive Sensor,” the company says. “If a certain number of consecutive measurements are irregular, Galaxy Watch warns the user of potential AFib activity, prompting them to take an ECG using their watch for a more accurate measurement.”