US users can now access blood pressure monitoring on the Galaxy Watch through Samsung’s Health Monitor app.
The company said the blood pressure monitoring technology works by calibrating values and changes in blood pressure to give users an estimate of their blood pressure.
Wearers can view systolic and diastolic measurements directly on their wrist.
Samsung said in a statement: “Compatible Galaxy Watches measure systolic and diastolic blood pressure along with your heart rate using the internal heart rate monitoring sensors.”
Users must calibrate their watch with their own upper-arm blood pressure cuff every 28 days.
Samsung said the feature will be available on Galaxy Watch4 and later released models with Watch OS 4.0 or higher and Android 12 or higher.
The company said the blood pressure monitoring feature is not intended to diagnose high blood pressure.
The technology adds to other health features on the Galaxy Watch series, including its Food and Drug Administration-cleared sleep apnoea feature and irregular heart rhythm notifications, as well as electrocardiogram, or ECG, readings.
Samsung said that later this year, users will have access to passive monitoring, which will show blood pressure trends over time.
In July last year, Samsung debuted its Galaxy Watch8 series, which included sleep apnoea detection, vascular stress monitoring and what it described as the first smartwatch antioxidant index, which allows wearers to track carotenoid levels.
According to the US Centers for Disease Control and Prevention, nearly half of US adults, 48.1 per cent or 119.9m people, have high blood pressure, but only about one in four individuals with elevated blood pressure have it under control.
Another company offering a wearable that measures a user’s blood pressure is Boston-based wearable fitness company WHOOP, which came under scrutiny from the FDA for its Blood Pressure Insights feature.
The agency claimed WHOOP improperly marketed its wearable without proper regulatory approval.
In a letter to the company, the FDA said Blood Pressure Insights qualifies as a medical device under federal law because it provides daily estimates of systolic and diastolic blood pressure, which the agency said are “inherently associated with the diagnosis of hypo- and hypertension, and is therefore intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment or prevention of disease.”
The FDA said it had not authorised Blood Pressure Insights for any use, and WHOOP has neither premarket approval nor 510(k) clearance for the feature.
The agency also claimed WHOOP failed to notify it before distributing the product, making the device both “adulterated” and “misbranded”.
WHOOP issued a statement disagreeing with the FDA’s claims and said Blood Pressure Insights is a wellness feature, not a medical device.
The dispute between WHOOP and the FDA is ongoing.
