Study in Support of FDA 510k Medical Device Clearance
TORONTO, ON / June 16, 2021 / AI/ML Innovations Inc. (CSE:AIML) (OTCQB:AIMLF) (“AIML” or the “Company”), a company committed to acquiring and advancing Artificial Intelligence/Machine Learning technologies that address urgent societal needs, is pleased to announce that its subsidiary, Health Gauge, 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 optimize the overall accuracy of Health Gauge’s latest wearable device (smart watch), The Phoenix, for blood pressure (BP), O2, and other predictive data relating to a patient’s 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, 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, as there is a direct correlation between an increase in the number of data sets and improved accuracy of the product, which benefits our HG Phoenix customers and enhances the possibility for improved health outcomes.”
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. (https://stinnovations.ca/)
On behalf of the Board of Directors
Tim Daniels, Executive Chairman
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