EDMONTON, March 10, 2023 – Health Gauge is pleased to announce that it has successfully completed a blood pressure validation study utilizing its best-in-class, wearable health monitoring solution, the “Phoenix”.
Bruce Matichuk, CTO and Co-founder of Health Gauge stated, “This is a significant step forward in the refinement and validation of Health Gauge’s solution. The next objective for us is completion of the FDA verification process, which would make Health Gauge’s Phoenix the only consumer style wearable approved as a Class 2 medical device for blood pressure, and would afford us many significant B2B and direct-to-consumer opportunities.”
SALIENT POINTS FROM THE BLOOD PRESSURE STUDY
The study results show Health Gauge’s solution is at or near the benchmark for regulatory certification as a Medical Device.
Health Gauge’s patented AI technology for cuffless blood pressure estimation was verified in the scientific study performed by the University of Alberta’s ST Innovations. The study demonstrated the effectiveness of machine learning to accurately estimate blood pressure using only Electrocardiogram and Photoplethysmogram data from the Phoenix watch.
Average of All Study Participants | After AI Training (mmHg) |
Systolic pressure (MAE) | 7.20 |
Systolic (SD) | 6.29 |
Diastolic pressure (MAE) | 6.20 |
Diastolic (SD) | 5.16 |
*MAE = Mean Absolute Error (relative to a medical-grade BP cuff)
*SD = Standard Deviation
*mmHg = a measurement used to record blood pressure
The study supports Health Gauge’s FDA 510k and Health Canada submission processes for clearance as a Class 2 medical device. The STI study demonstrated the efficacy of the Phoenix on a limited user set for estimating blood pressure, while full certification studies will utilize the same protocol with larger participant groups.
In addition to Blood Pressure, the Phoenix also tracks heart rate, heart rate variability, sleep, steps, distance, calories, blood oxygen, temperature and respiratory rate. The Health Gauge platform stores data on a user’s mobile device and synchronizes this data with a cloud server to enable data sharing with health professionals and care teams. Health Gauge offers a full platform for personal health and monitoring with many medical applications in the home, in hospitals and clinics.
About Health Gauge
Health Gauge’s patented solution is a personal health monitoring & management system, which combines the latest wearable health monitors with sophisticated artificial intelligence software tools and proprietary cloud computing software, to help caregivers, patients, and healthcare professionals access and utilize relevant data, resulting in better recovery outcomes and healthy living objectives through the ability to make immediate and better health choices. www.healthgauge.com
The Health Gauge platform provides the right balance of team and technology with the Health Gauge Phoenix wearable, the mobile Health Gauge App, and our VirtualCare solution that includes secured messaging, health information management and sharing, and virtual client engagement. It blends artificial intelligence with the latest sensors in non-invasive bio signal collection, including activity, sleep monitoring, HR, HR variability, and other rich personal health data through ECG & digital pulse analytics.
*The forward-looking statements in this press release are made as of the date of this press release, and the Company undertakes no obligations to update publicly or to revise any of the included forward-looking statements, whether because of new information, future events or otherwise, except as expressly required by applicable securities law.