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 routine access to clinically validated blood pressure measurement.
BP1000 functions by using technology analogous to an automated cuff, but instead leverages fingertip application. Users press down on sensors, following a visual target in the app, gradually reaching arterial occlusion.
It combines pressure sensing and photoplethysmography (PPG), an optical method tracking blood volume changes, to determine occlusion and calculate blood pressure through specific algorithms.
The app compiles each reading, maintaining a comprehensive measurement history.
Unlike previous cuffless technologies, BP1000 directly measures physiological parameters without needing individual calibration with a standard cuff device. This eliminates a significant barrier present in prior cuffless approaches.
Biozen plans to introduce BP1000 to the US market in phases, with broader commercial availability targeted for late 2026.
The early access programme is currently open to clinicians, partners, and individuals. The company intends to scale manufacturing and foster integration of its sensing platform into future medical devices.
Biozen chief scientific officer and the Georgia Institute of Technology electrical and computer engineering professor Omer Inan said: “The BP1000 isn’t built on black box estimation or correlation — it’s built on the same direct measurement principles that have defined accurate blood pressure for decades. FDA clearance reflects what the data shows — that, when done properly, this approach doesn’t require a cuff to be accurate.”
Biozen CEO Dikran Tourian said: “We’ve spent years proving that accurate blood pressure measurement doesn’t require a cuff. Nearly half of US adults have hypertension, yet for most people, measurement still happens only occasionally.
“FDA clearance allows us to begin making routine, clinically validated spot blood pressure measurement far more accessible.”
