Samsung Galaxy Watch Brings Blood Pressure Feature in the US Without FDA Approval

JAKARTA - Samsung officially launched a blood pressure monitoring feature for Galaxy Watch users in the United States, but with one important note: this feature has not received approval from the U.S. Food and Drug Administration.

The company insists that the technology is only intended for wellness needs, not as a medical device that can be used for diagnosis or treatment.

"This feature is designed to help users monitor blood pressure trends over time, but is not intended as a substitute for professional medical devices," said a Samsung official statement.

With its classification as a wellness feature, the device does not require FDA approval, as it does not make any medical claims. Samsung also said that this approach is in line with US regulatory policies that distinguish between consumer health devices and clinical medical devices.

This feature allows users to see their blood pressure patterns periodically. However, Samsung explicitly reminds users not to rely on it as a diagnostic tool. If an abnormal pattern is found, users are still advised to consult a medical professional.

The move marks an expansion of a feature that was previously only available in a number of international markets, finally reaching users in the US - albeit with regulatory limitations.

On the other hand, Apple takes a different approach through the Apple Watch. In 2025, the hypertension notification feature on the device has received FDA approval, allowing users to receive alerts if a high blood pressure pattern is detected within a certain period of time.

Even so, Apple also emphasized that the smartwatch is not a substitute for professional medical equipment - indicating that the boundary between wearable technology and clinical health devices is still quite firm.

This launch reflects a growing trend in the wearable industry: the integration of increasingly sophisticated health features, but still within the "health assistant" corridor, not the main diagnostic tool.

With the increasing interest in self-monitoring health, technology vendors are racing to bring innovative features. However, without regulatory validation such as the FDA, accuracy and reliability remain a major concern - and users are urged to remain critical.

Follow VOI Whatsapp Channel