– study in support of FDA 510k medical device clearance –
EDMONTON, June 16, 2021 – Health Gauge is pleased to announce that it has partnered with the University of Alberta’s ST Innovations regarding Neural Network data set validation work in support of Health Gauge’s FDA 510k and Health Canada submission processes for clearance as a Class 2 medical device. Additionally, this collaboration is designed to help refine and improve the overall accuracy and results of Health Gauge’s latest wearable device (smart watch), The Phoenix, for blood pressure, O2, and other predictive data relating to patient physiological information.
The workflow process with ST Innovations is designed to enhance Health Gauge’s data sets for artificial intelligence training by monitoring a number of research volunteers, with the primary objective of the study being the validation of The Phoenix against conventional data collection methods for blood pressure (cuff), photoplethysmography (PPG), spO2, and heart rate using a single‐lead ECG, and systemic temperature using an ear thermometer.
“This is significant work in that it helps create an even more robust and intuitive product,” said Randy Duguay, CEO of Health Gauge. “An aggregated data set is the foundation for our AI/ML platform, which can be applied and used by our HG Phoenix customers… essentially, the more data-sets that we have – the greater the accuracy and applicability for BP using the wrist-wearable device.”
ST Innovations, the business arm of the University of Alberta’s SMART Network, is Alberta’s leading R&D services organization, connecting entrepreneurs with world-class researchers in support of the latest innovation and R&D. Combining a leading research network, specialized equipment and market insights, ST Innovations is a health technology development center focused on accelerating innovative health ideas at every stage by providing customized services which identify and remove barriers to the health innovation development process.
About Health Gauge
Health Gauge’s patent-pending solution is a personal health monitoring and management system, which combines the latest wearable health monitors with sophisticated artificial 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
*Health Gauge is not a medical device and is not intended to diagnose, treat, cure, or prevent any disease. The Service is not meant as a substitute for, or an alternative to information from health care practitioners. If you have, or suspect you have, a medical condition, consult your doctor before using the Service, starting an exercise program, or changing your diet.