Happy Health’s Happy Ring has secured US Food and Drug Administration (FDA) clearance for blood pressure measurement, making it the first wearable to achieve clearance for ongoing, passive blood pressure measurement without either an inflatable cuff or calibration.
The Texas-based company validated its blood pressure technology against invasive arterial-line techniques, which measure blood pressure directly inside the artery and serve as a clinical reference standard. The FDA validation included 850 paired measurements across 85 patients, spanning normal blood pressure through Stage 2 hypertension – demonstrating a 0.8 mmHg mean error for systolic blood pressure and 0.1 mmHg mean error for diastolic blood pressure.