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Samsung brings BP monitoring to Galaxy Watches in the US (Updated: Clarification on FDA approval)

TL;DR
  • Samsung is bringing blood pressure monitoring to Galaxy Watches in the US for the first time.
  • The feature will be available on Galaxy Watch 4 and newer models running Wear OS 4 or later.
  • It relies on calibration with a traditional cuff-based monitor for accuracy.

Update: April 6, 2026 (12:26 AM ET): In an emailed clarification to Android Authority, Samsung said that the BP monitoring feature on Galaxy Watches in the US is not intended for medical use and therefore doesn’t require FDA clearance. Here’s Samsung’s full answer to our question about FDA approvals for the feature:

Samsung’s Blood Pressure Monitoring feature is designed as a wellness feature and is not intended for medical use. As such, it is not subject to FDA clearance. The feature aligns with the FDA’s General Wellness: Policy for Low-Risk Devices, including updates published in January 2026 focused on consumer wearables.



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