Galaxy Watch blood pressure monitoring isn't approved by the US FDA
SamMobile • • technology
Key Points:
- Samsung has introduced the blood pressure monitoring feature on its Galaxy Watch wearables in the United States, a capability previously limited to select markets.
- The company clarified that this feature does not have FDA approval and is not intended for medical use, classifying it as a wellness feature.
- Samsung emphasized that the Galaxy Watch's blood pressure monitoring should not be considered a substitute for medical-grade equipment and is designed to help users identify potential health issues.
- This approach aligns with the FDA's general wellness policy for consumer wearables, which does not require clearance for non-medical features.
- In contrast, Apple’s hypertension alerts on the Apple Watch received FDA approval in September last year, allowing it to provide alerts for potential high blood pressure based on 30 days of data.
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