Rockley Photonics Releases Positive Initial Results From Human Trials Of Laser-based Wearable Blood Pressure Monitor

Thursday, August 10, 2023

Rockley Photonics has shared promising results from two authorized human trials involving their first-generation Alpha prototype of a non-invasive, laser-based wearable blood pressure monitor, which is currently in advanced stages of development.

The initial study, involving 30 participants, effectively demonstrated the device's ability to track changes in blood pressure by comparing them to measurements obtained using an intra-arterial pressure transducer (known as an A-line), a gold-standard technique used for continuous blood pressure monitoring during surgical and ICU procedures. This was achieved by inducing blood pressure variations through a repeated leg press exercise. The device exhibited accuracy within a target range of -10 mmHg to +25 mmHg, aligning with FDA-recognized consensus standards ISO 81060-2 and IEEE 1708.

A subsequent longitudinal study followed subjects for up to 34 days post-calibration, matching the Rockley device's predictions against cuff-based measurements taken through dual-observer auscultation. Despite real-world variables such as device placement and other factors, the results displayed a strong correlation with the A-line study and remained consistent throughout the observation period.

These encouraging findings highlight the ongoing progress of Rockley's cuffless blood pressure monitor. Dr. Richard Kuntz, MD, a scientific advisor to Rockley and former Senior VP and Chief Medical and Scientific Officer at Medtronic, emphasized the potential impact of this device in enabling early diagnoses and continuous monitoring of cardiovascular conditions, thereby enhancing patient compliance and overall case management.

The device holds potential applications in managing hypertension in various patient groups, particularly in scenarios where frequent insights are crucial, such as cases involving white coat hypertension or regular treatments for heart failure or kidney disease.

Dr. Zahi Fayad, PhD, Director of the BioMedical Engineering and Imaging Institute at the Icahn School of Medicine at Mount Sinai, highlighted the significance of this technology in delivering frequent and accurate blood pressure measurements through a seamless wearable interface. He expressed anticipation for the device's further evolution to refine its capabilities and expand its range of applications.

Harvard Medical School - Leadership in Medicine Southeast Asia47th IHF World Hospital CongressHealthcare Innovation & Transformation SummitHealthcare CNO SummitHealthcare CMO SummitThe Healthcare Patient Experience & Engagement Summit 2024