Biozen Wins FDA 510(k) Clearance for BP1000 Cuffless Fingertip Blood Pressure Monitor

Oklahoma City-based Biozen received FDA 510(k) clearance for the BP1000, the first cuffless, calibration-free blood pressure device cleared in the US that delivers clinically validated spot-check readings from the fingertip. The device uses proprietary pressure sensing combined with photoplethysmography to identify arterial occlusion and compute blood pressure via physiologically informed algorithms — it measures directly rather than estimating. Unlike prior cuffless technologies, the BP1000 requires no per-user calibration against a standard cuff device. The device was validated against ISO 81060-2:2018. Biozen holds over 68 granted US and international patents and plans a phased US market introduction with broad commercial launch targeted for late 2026.