Biozen Receives FDA Clearance for First Calibration-Free Cuffless Blood Pressure Device
Tags Health Tech · Consumer · Hardware
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 combined with photoplethysmography, requiring no per-user calibration against a cuff. Protected by over 68 patents, the BP1000 will have a phased US market introduction with broad commercial launch targeted for late 2026.
Technical significance
Cuffless blood pressure monitoring has been a pursued goal for over a decade, with calibration requirements being the primary barrier to clinical validity. Biozen's approach — measuring the same underlying physiology as a cuff — is fundamentally different from optical-only approaches. If the clinical validation holds, this could enable continuous BP monitoring through wearable form factors.