Search Menu
Photonics Media Photonics Marketplace Photonics Spectra BioPhotonics Vision Spectra Photonics Showcase Photonics ProdSpec Photonics Handbook

Rockley Completes Human Studies of Blood Pressure Monitor

Facebook Twitter LinkedIn Email
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.
Sep 2023
BiophotonicslasershealthmonitoringBusinessRockley Photonicsblood pressurecufflesshuman studytrialFDAQ-substudydiagnosticsEuropeAmericas

back to top
Facebook Twitter Instagram LinkedIn YouTube RSS
©2023 Photonics Media, 100 West St., Pittsfield, MA, 01201 USA, [email protected]

Photonics Media, Laurin Publishing
x We deliver – right to your inbox. Subscribe FREE to our newsletters.
We use cookies to improve user experience and analyze our website traffic as stated in our Privacy Policy. By using this website, you agree to the use of cookies unless you have disabled them.