Loading...
News Article

Rockley completes human studies of blood pressure monitor

News

Laser-based wearable shows promise that it will perform as well as traditional cuff-based medical devices

Rockley Photonics has announced initial results from two human studies using a first-generation Alpha prototype of its non-invasive and laser-based cuffless blood pressure monitor. This 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 subjects participated in the study, where blood pressure changes were induced 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 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.

Rockley says that the results from the Alpha-wearable strongly justify the continued development of the Rockley cuffless blood pressure device. Richard Kuntz, MD, scientific advisor to Rockley said: “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.

Zahi Fayad, director of the BioMedical Engineering and Imaging Institute at the Icahn School of Medicine at Mount Sinai said: “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 the FDA in the coming months to obtain feedback on future clinical study design and data analysis.

QD company Quantum Science expands into new facility
Innoscience files lawsuit against Infineon
Riber revenues up 5% to €41.2m
Forvia Hella to use CoolSiC for next generation charging
Photon Design to exhibit QD simulation tool
Ortel transfers CW laser fabrication to Canada
Luminus adds red and blue multi-mode Lasers
PseudolithIC raises $6M for heterogeneous chiplet tech
Mesa sidewall design improves HV DUV LEDs
IQE revenue to exceed expectations
'Game-changing' VCSEL system targets clinical imaging
German start-up secures finance for SiC processing tech
Macom signs preliminaries for CHIPS Act funding
IQE and Quintessent partner on QD lasers for AI
EU funds perovskite tandems for fuel-free space propulsion
EU to invest €3m in GeSi quantum project
Transforming the current density of AlN Schottky barrier diodes
Turbocharging the GaN MOSFET with a HfO₂ gate
Wolfspeed launches Gen 4 SiC MOSFET technology
Report predicts high growth for UK's North East
Element Six unveils Cu-diamond composite
SemiQ launches hi-rel 1700V SiC MOSFETs
Lynred to exhibit Eyesential SWIR sensor for machine vision
Thorlabs buys VCSEL firm Praevium Research
Advancing tuneable InP lasers on a heterogeneous platform
P-GaN gate HEMTs have record threshold voltage
Guerrilla RF releases GaN power amplifier dice
Narrow-linewidth DFB lasers now at 405 and 488nm
Researchers develop tech for future fast-charging stations
Vermont GaN Tech Hub awarded nearly $24M
Onsemi completes buy-out of Qorvo SiC JFET business
Quantum Science announces Innovate UK funding
×
Search the news archive

To close this popup you can press escape or click the close icon.
Logo
x
Logo
×
Register - Step 1

You may choose to subscribe to the Compound Semiconductor Magazine, the Compound Semiconductor Newsletter, or both. You may also request additional information if required, before submitting your application.


Please subscribe me to:

 

You chose the industry type of "Other"

Please enter the industry that you work in:
Please enter the industry that you work in: