Samsung Galaxy Watch's Blood Pressure Feature Arrives in U.S., Lacks FDA Approval

Samsung's Galaxy Watch wearables have included a blood pressure monitoring feature in specific markets, with the United States not being among them until recently. The arrival of this feature in the U.S. was confirmed late last month. Samsung has since clarified that the feature lacks FDA approval.

In a statement to AndroidAuthority, Samsung confirmed the feature is not intended for medical use, which is why it does not require FDA clearance.

The company stated it is “designed as a wellness feature” and aligns with the FDA’s guidance on general wellness policy for consumer wearables.

Users are advised that the Galaxy Watch's blood pressure monitoring should not be considered an alternative to medical-grade equipment.

Companies like Samsung and Apple integrate these features into wearables to help users identify potential health issues, prompting them to seek medical professional assistance, rather than to replace medical tools.