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- Rockley’s first-generation blood pressure (BP) monitor tracks changes in subjects’ BP in a gold standard arterial-line reference study, with results compared to FDA-recognized consensus standards ISO 81060-2 and IEEE 1708.
- Findings demonstrate stable BP prediction over a one-month longitudinal study with no observed increase in error after single calibration.
- Results provide further evidence of the capabilities of Rockley’s laser-based technology, building upon previously published findings.
- Technical white paper with detailed findings can be found on rockleyphotonics.com.
OXFORD, England, and IRVINE and PASADENA, Calif. August 9, 2023
Rockley Photonics is excited to announce the initial results from two important IRB-approved human studies using a first-generation Alpha prototype of their non-invasive and laser-based cuffless blood pressure monitor. This innovative, wearable 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. Thirty (30) subjects participated in the study, where blood pressure changes were induced using a repeated leg press exercise.
Utilizing only the Rockley laser-based signal and a single-point blood pressure calibration, blood pressure changes from -10 mmHg to +25 mmHg were within target accuracy according to both 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 ages 18 and 71 years.
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 BP 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.
The results from the Alpha wearable strongly justify the continued stepwise and thoughtful development of the Rockley cuffless blood pressure device. Dr. Richard Kuntz, MD, scientific advisor to Rockley and former Senior VP, Chief Medical and Scientific Officer at Medtronic, stated, “Reliable acquisition of blood pressure is necessary to aid in the early diagnosis and continued monitoring of patients that require management of a variety of cardiovascular conditions. Rockley’s device shows promise that it will perform with the accuracy expected from traditional medical devices, which can vastly improve patient compliance and overall case management.”
Potential use cases for the device focus on management of hypertension in various patient populations, where frequent insight may be leveraged in challenging-to-monitor scenarios, such as those that experience white coat hypertension or undergo regular treatments for kidney disease or heart failure.
Dr. Zahi Fayad, PhD., Director of the BioMedical Engineering and Imaging Institute at the Icahn School of Medicine at Mount Sinai stated, “There’s an art to taking a reliable blood pressure measurement using a traditional cuff. However, blood pressure measurements using wearables have long been a challenge. “It is very exciting to see this cuffless technology becoming available, as it enables frequent measurements and can provide a seamless and easy practitioner and patient experience,” Fayad continued. “Rockley’s current findings show accurate blood pressure values compared to a gold standard over a certain range. I am excited to see the continuation of the program to generalize the findings.”
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.
About Rockley Photonics
Rockley is a global leader in photonics-based health monitoring, invested in discovering new ways to measure important biometrics using novel sensing techniques. Rockley is developing a comprehensive range of photonic integrated circuits, sensors, and full-stack solutions. From next-generation biosensing platforms to mobile health monitoring, Rockley is laying the foundation for a new era of precision medicine.
Rockley believes that photonics will eventually become as pervasive as micro-electronics and has developed a platform with the power and flexibility needed to address the medical device and technology market through a wide variety of vertical applications.
The company has partnered with numerous tier-1 customers, spanning a range of industries to deliver the complex optical systems required to bring transformational products to life. Rockley is dedicated to pushing the boundaries of what is possible with photonics technology to create new solutions for a wide range of comprehensive monitoring applications, with an aim to revolutionize how people manage their health.
Contact Information:
Please email us at contact@rockleyphotonics.com or visit rockleyphotonics.com to learn more.
出典： https://rockleyphotonics.com/2023/08/09/rockley-photonics-advances-development-of-its-wearable-laser-based-blood-pressure-monitor-with-successful-completion-of-human-studies/
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