AI-powered wearable completes blood pressure validation study

Health Gauge has successfully completed a blood pressure validation study on its AI-powered wearable health monitoring device. 

AI/ML Innovations Inc, has reported that its subsidiary, Health Gauge Inc, has successfully completed a blood pressure validation study on its wearable health monitoring solution, the Phoenix.

Health Gauge’s personal health monitoring and management system combines wearable health monitors with artificial intelligence software tools and proprietary cloud computing software to help patients, caregivers and healthcare professionals access relevant data.

Its patented AI technology for cuff-less blood pressure estimation was verified in the scientific study performed by the University of Alberta’s ST Innovations. 

The company announced in a press release that the study has demonstrated the effectiveness of machine learning to accurately estimate blood pressure using only Electrocardiogram and Photoplethysmogram data from the Phoenix watch.

Results show Health Gauge’s solution to be at or near the benchmark for regulatory certification as a Medical Device. 

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 utilise 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 synchronises this data with a cloud server to enable data sharing with health professionals and care teams. 

Bruce Matichuk, CTO of AI/ML Innovations, and co-founder of Health Gauge, commented: “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.”