AI/ML Innovations' Health Gauge Concludes Successful Blood Pressure Validation Study on its AI-Powered Health Monitoring Solution
AI/ML Innovations Inc. (CSE:AIML)(OTCQB:AIMLF) announced that its subsidiary, Health Gauge Inc., completed a successful blood pressure validation study for its wearable device, the Phoenix. This study indicates the device's compliance with regulatory standards for medical devices. The CTO noted the importance of finishing the FDA verification process, which would make Phoenix a Class 2 medical device approved for blood pressure monitoring. The study showcased the effectiveness of Health Gauge's AI technology, revealing minimal mean absolute errors in blood pressure estimations. This milestone supports upcoming FDA and Health Canada submissions, enhancing future business opportunities.
- Successful completion of blood pressure validation study for the Phoenix wearable device.
- Minimally invasive blood pressure estimation showed mean absolute errors of 7.20 mmHg (systolic) and 6.20 mmHg (diastolic).
- Supports upcoming FDA 510k and Health Canada submissions for Class 2 medical device approval.
- None.
TORONTO, ON / ACCESSWIRE / March 6, 2023 / AI/ML Innovations Inc. (CSE:AIML)(OTCQB:AIMLF)(FWB:42FB), a company committed to acquiring and advancing Artificial Intelligence/Machine Learning technologies that address urgent societal needs, is pleased to report that its wholly owned subsidiary, Health Gauge Inc., has successfully completed a blood pressure validation study utilizing its best-in-class, wearable health monitoring solution, the "Phoenix".
Bruce Matichuk, CTO of AI/ML Innovations, and Co-founder of Health Gauge Inc. 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 to be 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 www.healthgauge.com
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.
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.
About AI/ML Innovations Inc. https://aiml-innovations.com/
AI/ML Innovations Inc. has realigned its business operations to capitalize on the burgeoning fields of artificial intelligence (AI) and machine learning (ML), with an initial investment focus on emerging digital health and wellbeing companies that leverage AI, ML, cloud computing and digital platforms to drive transformative healthcare management solutions and precision support delivery across the health continuum. Through strategic partnerships with Health Gauge (
On behalf of the Board of Directors
Tim Daniels, Executive Chairman
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For further information, contact: Blake Fallis at (778) 405-0882 or info@aiml-innovations.com.
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SOURCE: AI/ML Innovations Inc.
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FAQ
What are the results of the blood pressure validation study conducted by AIML Innovations?
What is the significance of the FDA verification process for the Phoenix device by AIMLF?
When did AIML Innovations announce the completion of the blood pressure validation study?
How does the Phoenix wearable device measure blood pressure?
