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AI/ML Innovations Inc.'s Health Gauge Seeking FDA Approval for Its Patented Blood Pressure Measurement Technology

AI/ML Innovations Inc.'s Health Gauge Seeking FDA Approval for Its Patented Blood Pressure Measurement Technology

AI/ML Innovations Inc.'s Health Gauge的专利血压测量技术正在寻求FDA的批准
Accesswire ·  02/27 08:30

Highlights:

亮点:

  • 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 .
  • 该公司专有的血压测量神经网络的FDA 510(k)二类(软件即医疗器械)认证开始生效。
  • 首款包含公司神经网络的产品是 “Follow Your Heart”,这是一款具有医疗级精度的消费类健康可穿戴智能手表解决方案。

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.:

不列颠哥伦比亚省维多利亚州/ACCESSWIRE/2024年2月27日/ AI/ML Innovations Inc.(以下简称 “公司”)(CSE: AIML)(OTCQB: AIMLF)(FWB: 42FB)是一家致力于收购和推进满足紧急社会需求的人工智能/机器学习技术的领先公司,很高兴从其控股子公司Health Gauge Inc.获得以下信息:

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.

经过三年的密集研发之旅,Health Gauge的人工智能和机器学习开发团队自豪地宣布,他们的高级血压测量神经网络已成功训练。这一成就标志着一个关键时刻,因为该公司现在将为 “软件即医疗器械” 寻求FDA(510(k)二级)认证。我们的专有技术有望在消费类可穿戴智能手表设备中提供高效的血压测量,同时提供无与伦比的准确性,从而改善医疗保健结果。

"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.

“Follow Your Heart” 是EdgeAI的非侵入性血压测量——即将公开发布的 “Follow Your Heart” 利用公司的专有EdgeAI技术,通过公司的智能传感器手表提供非侵入性血压测量,为用户提供方便、有效的健康和保健监测解决方案。

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 "

Health Gauge首席执行官兰迪·杜瓜伊表示:“我们很高兴我们的神经网络培训和验证工作表明,作为二类血压医疗器械,我们能够达到或超过美国食品药品管理局的要求。实际上,这意味着我们的可穿戴设备能够以与医生办公室的医用级血压袖带相当的精度运行,但只需佩戴手表即可”。杜瓜伊继续说:“高血压患病率的增长是推动全球血压袖带市场规模的重要因素。全球超过14%的人口患有高血压,这增加了患心血管疾病的风险。预计从2023年到2031年,全球血压测量市场将以6.5%的复合年增长率增长,到2031年底达到10亿美元。 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."

AI/ML Innovations Inc.首席执行官保罗·达菲补充说:“Health Gauge在血压测量技术方面的突破是健康科技行业向前迈出的重大飞跃。我们很荣幸能与一家在推动技术前沿方面不断表现出卓越表现的公司合作。这一成就符合我们的集体愿景,即创造塑造医疗保健未来的创新解决方案。”

About Health Gauge

关于生命值计

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.

Health Gauge是AI/ML Innovations Inc.的多数股权子公司,站在通过健康情报的力量彻底改变医疗保健的最前沿。Health Gauge致力于利用技术促进人类福祉,为个性化健康见解提供尖端解决方案。

About AI/ML Innovations Inc.

关于 AI/ML Innovations Inc.

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".

AI/ML Innovations Inc.调整了其业务运营,以利用新兴的人工智能(AI)和机器学习(ML)领域,最初的投资重点是新兴的数字健康和福祉公司,这些公司利用人工智能、机器学习、云计算和数字平台推动变革性的医疗管理解决方案和整个健康连续体的精准支持交付。通过与Health Gauge(AIML持有95.2%的股权)、Tech2Heal(高达22%的所有权,目前由AIML持有12.44%的所有权)、AI Rx Inc.(AIML持有70%的股权)以及其他计划中的增值投资,公司继续利用不断扩大的增长领域,使公司所有利益相关者受益。AI/ML的股票在加拿大证券交易所交易,代码为 “AIML”,OTCQB风险投资市场以 “AIMLF” 的形式交易,在法兰克福证券交易所交易的代码为 “42FB”。

On behalf of the Board of Directors

代表董事会

Tim Daniels, Executive Chairman

蒂姆·丹尼尔斯,执行主席

For more information about AI/ML Innovations:

有关 AI/ML 创新的更多信息:

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

有关详细信息,请访问AI/ML的网站或公司的归档文件
欲了解更多信息,请致电 (778) 405-0882 或 info@aiml-innovations.com 与 Blake Fallis 联系

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.

CSE及其监管服务提供商(该术语在CSE的政策中定义)均不对本新闻稿的充分性或准确性承担责任。

For AI/ML Innovations Investors

致人工智能/机器学习创新投资者

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 .

本新闻稿中发表的某些非基于历史信息的陈述是前瞻性陈述,涉及大量已知和未知的风险和不确定性。本新闻稿包含与AI/ML Innovations对管理层计划、目标和战略(包括捍卫公司知识产权的战略)的预期有关的明示或暗示的前瞻性陈述。这些陈述既不是承诺也不是担保,但存在各种风险和不确定性,其中许多风险和不确定性是我们无法控制的,这可能导致实际结果与这些前瞻性陈述中设想的结果存在重大差异。提醒现有和潜在投资者不要过分依赖这些前瞻性陈述,这些陈述仅代表截至本文发布之日。除非适用的证券法明确要求,否则AI/ML Innovations Inc. 没有义务更新或修改本新闻稿中包含的信息,无论是由于新信息、未来事件或情况还是其他原因。有关不确定性和风险的更多信息,可以在AI/ML向证券监管机构提交的披露文件中找到,网址为。

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SOURCE: AI/ML Innovations Inc.

来源:AI/ML Innovations Inc.


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