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AI/ML INNOVATIONS INC. (:AIML) AI/ML Innovations Inc.'s Health Gauge Seeking FDA Approval for Its Patented Blood Pressure Measurement Technology

Transparency directive : regulatory news

27/02/2024 14:30

Highlights:

  • FDA 510(k) Class II (Software as a Medical Device) certification commences for the Company's proprietary Blood Pressure Measurement Neural Network.
  • The first product release to include the Company's Neural Network is "Follow Your Heart", a consumer wellness wearable smartwatch solution with medical grade accuracy .

VICTORIA, BC / ACCESSWIRE / February 27, 2024 / AI/ML Innovations Inc. (the "Company") (CSE:AIML)(OTCQB:AIMLF)(FWB:42FB), a leading company committed to acquiring and advancing Artificial Intelligence/Machine Learning technologies that address urgent societal needs, is pleased to have received the following from its majority-owned subsidiary, Health Gauge Inc.:

After an intensive, three-year journey in research and development, the AI and ML Development team at Health Gauge proudly announces the successful training of their advanced Blood Pressure Measurement Neural Network. This achievement marks a pivotal moment, as the Company will now seek FDA (510(k) Class II) Certification for "Software as a Medical Device". Our proprietary technology is poised to advance healthcare outcomes by providing efficient blood pressure measurements in a consumer wearable smartwatch device while delivering unsurpassed accuracy.

"Follow Your Heart", a Non-Invasive Blood Pressure Measurement with EdgeAI - Soon to be publicly released, "Follow Your Heart" utilizes the Company's proprietary EdgeAI technology, providing a non-invasive blood pressure measurement through the Company's Smart Sensor Watch, that offers users a convenient, effective health & wellness monitoring solution.

Randy Duguay, CEO of Health Gauge, stated "We are thrilled that our Neural Net training and validation efforts show that we are able to meet or surpass the FDA requirements as a Class II medical device for blood pressure. In practical terms, this means our wearable is able to perform with a comparable degree of accuracy as a medical grade blood pressure cuff found in your doctor's office, but with the convenience of simply wearing a watch". Duguay continued, "Growth in prevalence of hypertension is a prominent factor driving the global blood pressure cuffs market size. More than 14% of the global population is afflicted with hypertension, which increases the risk of cardiovascular diseases. The global market for blood pressure measurement is expected to grow at a CAGR of 6.5% from 2023 to 2031 and reach US$ 1.0 Bn by the end of 2031. 1 "

Paul Duffy, CEO of AI/ML Innovations Inc., added, "Health Gauge's breakthrough in blood pressure measurement technology is a significant leap forward for the health tech industry. We are proud to be associated with a company that continually demonstrates excellence in pushing technological frontiers. This achievement aligns with our collective vision of creating innovative solutions that shape the future of healthcare."

About Health Gauge https://www.healthgauge.com/

Health Gauge, a majority-owned subsidiary of AI/ML Innovations Inc., is at the forefront of revolutionizing healthcare through the power of Health Intelligence. With a commitment to leveraging technology for human well-being, Health Gauge provides cutting-edge solutions for personalized health insights.

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 (95.2% owned by AIML), Tech2Heal (up to 22% ownership rights, with 12.44% currently owned by AIML), AI Rx Inc. (70% owned by AIML) and other planned accretive investments, the Company continues to capitalize on expanding growth areas, to the benefit of all the Company's stakeholders. AI/ML's shares are traded on the Canadian Securities Exchange under the symbol "AIML", the OTCQB Venture Market under "AIMLF", and the Frankfurt Stock Exchange under "42FB".

On behalf of the Board of Directors

Tim Daniels, Executive Chairman

For more information about AI/ML Innovations:

For detailed information please see AI/ML's website or the Company's filed documents at www.sedarplus.ca
For further information, contact: Blake Fallis at (778) 405-0882 or info@aiml-innovations.com

Neither the CSE nor its Regulation Services Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

For AI/ML Innovations Investors

Certain statements made in this press release that are not based on historical information are forward-looking statements that involve substantial known and unknown risks and uncertainties. This press release contains express or implied forward-looking statements relating to, among other things, AI/ML Innovations' expectations concerning management's plans, objectives, and strategies, including strategies for defending the Company's intellectual property. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. AI/ML Innovations Inc. undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events, or circumstances or otherwise except as expressly required by applicable securities law. Further information regarding the uncertainties and risks can be found in the disclosure documents filed by AI/ML with the securities regulatory authorities, available at www.sedar.com.



View the original press release on accesswire.com



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