Biozen Receives FDA Clearance for First Calibration-Free Cuffless Blood Pressure Device
Tags Consumer
Biozen received FDA 510(k) clearance for the BP1000, the first cuffless blood pressure device cleared in the US to deliver calibration-free, clinically validated spot measurements from the fingertip. The device uses direct arterial occlusion measurement via the fingertip combined with photoplethysmography (PPG), requiring no per-user calibration against a cuff — a key limitation of prior cuffless approaches. Protected by over 68 granted US and international patents, Biozen plans a phased US market introduction with broad commercial launch targeted for late 2026. Nearly half of US adults have hypertension, yet most measure only occasionally.
Technical significance
Calibration-free cuffless BP measurement has been a pursued goal in health tech for over a decade. Biozen's approach — measuring the underlying physiology directly via arterial occlusion rather than estimating from indirect signals — could enable routine, clinically validated blood pressure monitoring outside clinical settings. If successful at scale, this shifts hypertension management from periodic screening to continuous monitoring, with implications for medication adherence and early intervention.