Study finds advanced biometric sensor technology at the finger provides cuff-like accuracy when evaluated according to the ISO 81060-2 standard without the need for a blood pressure cuff or calibration
During a presentation on May 15th to the American College of Cardiology, Dr. Steven LeBoeuf, President and Co-Founder of Valencell, a company focused on the science of wearable biometrics, outlined findings of a clinical study showcasing how Valencell’s advanced biometric software enables photoplethysmography (PPG) sensors to estimate blood pressure (BP) with cuff-like accuracy. As part of the ACC’s 70th Annual Scientific Session, the poster presentation highlights Valencell’s ability to analyze finger PPG data and generate accurate blood pressure measurements without the need for a cuff and without requiring a user calibration.
In the extensive study, over 4,000 participants received three sequential readings: a manual auscultatory BP reading, an automatized oscillometric cuff BP readings and a PPG reading of blood flow volumes from the finger. With manual readings serving as the ground-truth for training, an advanced machine learning model was developed to predict systolic and diastolic measurements based solely on finger-PPG sensor data. To prove the broad generalization of the model, the accuracy of the model was assessed with a test dataset comprising subject data that was never used in the training dataset. Compared with the manual auscultatory blood pressure readings, the accuracy was found to be within 0 ±7.9 mmHg and 0.4 ±7.4 mmHg for systolic blood pressure (SBP) and diastolic blood pressure (DBP), respectively.
This is the first time a cuffless, calibration-free finger-PPG solution for accurately predicting blood pressure has been presented to the American College of Cardiology and has exciting connotations for patient care and consumer health. Daily self-monitoring of BP is widely recognized as a cost-effective method to identify and manage hypertension. However, few American households own BP monitors and even less comply with daily monitoring in part due to annoyances associated with porting and properly donning a BP cuff. This technology opens the way for BP trends to be continuously and seamlessly monitored using smartphones, watches, and other devices.
“Given the rigorous scientific review process of the American College of Cardiology, it is a privilege to be presenting data to the congress for a second year in succession,” said Dr. Steven LeBoeuf, President, and Co-Founder of Valencell. “Last year, we presented clinical data showing the effectiveness of PPG data taken from the ear in accurately predicting blood pressure, and we are excited to be showing similarly robust results for finger-based data. For over a decade, Valencell has been breathing life into PPG sensor data with advanced software capable of accurately measuring heart rate, respiration rate, RR-interval, and other biometrics throughout daily life activity. Studies such as these and the advances of machine learning are helping to drive the digital therapeutic revolution, improve patient outcomes and drive down healthcare costs. We are proud to be foundational players in the space.”
The use of wearables to measure BP is a hot topic. Two technologies are vying for prominence, including the use of ECG or Pulse Transit/Arrival Time and PPG sensors. While both have merit, unlike ECG or pulse transit time, the Valencell’s technology does not need to be calibrated to a BP cuff and does not require two different sensors. It only requires data from a single PPG sensor module, the type already in widespread use in wearables today.
As a world leader in the science of wearable biometrics, Valencell’s inventions have been commercialized in tens of millions of devices for companies such a Samsung, Bose, Jabra, Huawei, Suunto, and Sony. Its latest capabilities can be built into a range of passive form-factors worn in the ear, on the finger, and on the wrist, making it significantly easier for people to monitor their BP regularly and build life-saving habits. The company is pursuing FDA clearance for this new technology later in 2021 to help manufacturers who embed the technology in their devices to move forward with the clearance process.
Full results of the 2021 PPG Finger Data study presented to The America College of Cardiology can be viewed here. Results of the 2020 study showing the effectiveness of PPG sensors worn in the ear to predict BP can be viewed here. For more information, please contact Valencell at: https://valencell.com/contact-