Samsung Brings Blood Pressure Monitoring to Galaxy Watches in the US After Years of Regulatory Limbo
Samsung has begun a phased rollout of blood pressure monitoring to US Galaxy Watch owners, classifying the feature as a wellness tool under the FDA's updated General Wellness Policy rather than seeking medical device clearance.
Overview
Samsung has activated blood pressure monitoring for Galaxy Watch users in the United States, ending a years-long wait for a feature that had been available in South Korea since 2020. The phased rollout began on March 31, 2026, through an update to the Samsung Health Monitor app, and supports all Galaxy Watch models from the Watch 4 onward, as reported by Bloomberg.
The launch comes with a significant regulatory caveat: Samsung has classified the feature as a wellness tool rather than a medical device, aligning it with the FDA’s General Wellness Policy for Low-Risk Devices rather than pursuing formal FDA clearance. The distinction determines both what the feature can claim to do and how consumers should interpret its readings.
What We Know
The blood pressure monitoring feature uses pulse wave analysis through the Galaxy Watch’s built-in optical heart rate sensor. Users initiate a reading manually from the wrist, and the watch displays systolic and diastolic pressure along with heart rate, according to 9to5Google.
Accuracy depends on a calibration step that requires a traditional upper-arm blood pressure cuff, sold separately. Users must recalibrate every 28 days by taking a reading with both the cuff and the watch simultaneously, establishing a baseline against which the watch’s sensor-based estimates are adjusted. Without recalibration, the feature stops providing readings.
Compatible devices include the Galaxy Watch 4, 5, 6, 7, and Galaxy Watch 8 series. The watch must run Wear OS 4.0 or higher and be paired with a Samsung Galaxy smartphone running Android 12 or later. The feature does not work with non-Samsung Android phones or iPhones, as reported by TechRadar.
Samsung has stated explicitly that the blood pressure readings are “not intended to prevent or diagnose high blood pressure” and should not replace clinical-grade monitoring equipment. The company positions the feature as a tool for tracking trends over time, encouraging users to consult a physician for medical concerns.
The regulatory pathway Samsung chose avoids the lengthy FDA 510(k) or De Novo clearance process by classifying blood pressure monitoring as a general wellness feature. The FDA’s updated General Wellness Policy, revised in January 2026 with provisions specifically addressing consumer wearables, permits health-related tracking features that are marketed for wellness purposes rather than diagnosis or treatment.
What We Don’t Know
Samsung has not published clinical validation data specific to the US rollout, and the accuracy margins of pulse wave analysis compared to clinical-grade oscillometric cuffs remain unspecified in public materials. Independent studies on earlier international versions of Samsung’s blood pressure feature have shown variable accuracy depending on user posture, wrist position, and skin tone, but Samsung has not addressed whether the US release incorporates improvements.
The timeline for Samsung’s planned passive monitoring feature, which would track blood pressure trends continuously without requiring manual readings, has not been specified beyond “later in 2026.” It is unclear whether passive monitoring would require any additional regulatory classification.
How the FDA will respond to the growing number of wearable companies using the General Wellness Policy to offer health metrics without medical device clearance is also an open question. Apple took a different approach with its hypertension detection feature on the Apple Watch, which received FDA clearance in September 2025 but provides alerts about blood pressure patterns rather than numerical readings.
Analysis
The Samsung rollout highlights a widening gap in how major wearable manufacturers approach health feature regulation in the United States. Apple pursued FDA clearance for its blood pressure-adjacent feature, which limits functionality to pattern-based alerts but carries regulatory endorsement. Samsung opted for the wellness classification, which allows numerical blood pressure readings but without the clinical validation that FDA clearance would require.
The 28-day recalibration requirement is a practical constraint that limits the feature’s appeal as a standalone health tool. Users who do not already own a blood pressure cuff must purchase one, and those who forget to recalibrate lose access to the feature entirely. This dependency on traditional hardware undercuts the convenience argument for wrist-based monitoring.
For the broader digital health industry, the US launch tests whether consumers will adopt wearable blood pressure tracking at scale despite the wellness-only classification. If uptake is strong, it may encourage other manufacturers to bring similar features to market under the General Wellness Policy, potentially accelerating a trend that health regulators will need to monitor closely.