Biozen to Present Prospective Clinical Validation Data at ACC 2026
The presentation will feature results from a prospective study evaluating Biozen's measurement device against the clinical gold standard, conducted in accordance with the ISO 81060-2:2018 validation protocol, the internationally recognized standard for noninvasive blood pressure device evaluation.
The study evaluated 264 participants and tested the Biozen device under prospective conditions, meaning the device and algorithms were finalized prior to the study and remained unchanged during testing.
Using proprietary pressure sensing and optical sensing in conjunction with physiologically-informed algorithms, Biozen's ultra-compact BP1000 device, coupled with a companion app, directly measures blood pressure by occluding the artery at the fingertip.
"Blood pressure measurement hasn't fundamentally changed in decades. We've built a new way to do it—one that's grounded in physiology without the need for a cuff or calibration," said
"The study was designed to evaluate the device as it would be used in practice," said Omer Inan, PhD, Chief Scientific Officer of Biozen. "Prospective evaluation under the ISO validation framework is an important milestone for demonstrating the performance of our cuffless blood pressure technology."
The study included over-representation of participants with Fitzpatrick V & VI skin tone, and Obesity Class I & II, populations that have historically presented challenges for cuffless blood pressure monitoring systems.
Biozen's presentation at ACC reflects continued progress toward scalable, physiology-based blood pressure measurement and monitoring technologies.
About Biozen
Biozen, LLC is a privately held digital health company headquartered in
Note: The Biozen BP Sensor and BP1000 are investigational devices and are not yet cleared by the U.S. Food and Drug Administration (FDA) for commercial distribution.
For more information, visit biozen.com.
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SOURCE Biozen, LLC
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