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Biozen secures FDA 510(k) clearance for BP1000 device
Biozen has secured the US FDA 510(k) clearance for its BP1000 device, a calibration-free, cuffless blood pressure device for spot measurement from the fingertip. Biozen plans to introduce BP1000 to the US market in phases, with broader commercial availability targeted for late 2026. The device aims to address challenges in routine access to clinically validated blood pressure measurement. Credit: Brian A Jackson / Shutterstock.com. Biozen has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its BP1000 device, a calibration-free, cuffless blood pressure solution for spot measurement from the fingertip. The device aims to address challenges in…
Biozen has secured the US FDA 510(k) clearance for its BP1000 device, a calibration-free, cuffless blood pressure device for spot measurement from the fingertip.
Source: Medical Device Network