Biozen in OKC wins FDA clearance for cuffless blood pressure device

▤ Summary

Biozen won FDA 510(k) clearance for its BP1000, the first U.S.-cleared cuffless device that delivers calibration-free, clinically validated blood pressure readings from the fingertip. The device combines proprietary pressure sensing with photoplethysmography and physiologically informed algorithms, and it validated performance against the ISO 81060-2:2018 standard. Biozen plans a phased U.S. rollout with an early access program now and a broad commercial launch targeted for late 2026 while scaling manufacturing and partnerships. The privately held company is headquartered in Oklahoma City with R&D in Atlanta and holds more than 68 granted U.S. and international patents covering its platform.

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