Galaxy Watch blood pressure monitoring isn't approved by the US FDA

It's been a few years since Samsung introduced the blood pressure monitoring feature on its Galaxy Watch wearables. This feature has only been available in select markets, and the United States was not one of them.

The wait finally ended for users in the country late last month when Samsung finally confirmed the arrival of the Galaxy Watch blood pressure monitoring feature in the country. However, the company has now clarified that this feature doesn't have FDA approval.

Samsung has confirmed in a statement provided to AndroidAuthority that this feature isn't intended for medical use, which is why it doesn't require FDA clearance.

It says in the statement that this is “designed as a wellness feature” that's not for medical use. “As such, it is not subject to FDA clearance,” while highlighting that the feature aligns with FDA's latest guidance on general wellness policy for consumer wearables.

The company is basically notifying users that even though their Galaxy Watch is capable of measuring their blood pressure, they shouldn't think of it as an alternative to a medical-grade blood pressure monitor.

Companies like Samsung and Apple have built these features into their wearable devices merely to help users spot a potential health issue so that they can seek assistance from a medical professional. They're not meant to replace medical tools.

However, it's pertinent to note here that the Apple Watch's hypertension alerts tool was approved by the FDA in September last year. The watch can send an alert once analyzing blood pressuring for 30 days if patterns consistent with high blood pressure are detected. Users are then advised to consult a doctor for any treatment.