Rockley Completes Human Studies of Blood Pressure Monitor
OXFORD, England, Aug. 24, 2023 — Rockley Photonics has completed two IRB-approved human studies using a first-generation Alpha prototype of their noninvasive laser-based cuffless blood pressure monitor. The device is currently in advanced development.
The first study successfully demonstrated intra-subject tracking of blood pressure compared to measurements using an intra-arterial pressure transducer, or an A-line, which is the gold-standard method to continuously monitor blood pressure during surgery and in the ICU. The study looked at 30 subjects who induced blood pressure changes using a repeated leg press exercise.
Using only the Rockley laser-based signal and a single-point blood pressure calibration, blood pressure changes from −10 to 25 mmHg were within target accuracy according to FDA-recognized consensus standards ISO 81060-2 and IEEE 1708. Future studies will focus on expanded blood pressure ranges.
A second longitudinal study followed subjects with repeat visits up to 34 days post-calibration. Here, Rockley device predictions were compared to dual-observer auscultation measurements (cuff-based with split stethoscope). Subjects included both healthy and hypertensive adult volunteers between 18 and 71 years old.
Despite real-world variability in device placement, the use of multiple devices per subject, and higher reference error, the longitudinal study results were comparable to the A-line study over the same blood pressure range, and within sight of meeting the ISO 81060-2 and IEEE 1708 accuracy targets. Notably, the error did not increase over the time period from initial calibration.
Rockley plans to engage with FDA via the Q-sub process in the coming months to obtain feedback on future clinical study design and data analysis.
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