AIML Hits Key Regulatory Benchmark with 510(k) Filing for MaxYield(TM) Signal Enhancement Platform

Rhea-AI Summary

AI/ML Innovations (AIML) has submitted a 510(k) premarket notification to the FDA for its MaxYield™ platform, a cloud-native solution designed to enhance ECG signal quality. The platform uses proprietary neural network algorithms to reduce noise and improve waveform clarity in ECG signals across 1- to 12-lead configurations for adult patients 18 and older.

MaxYield is compatible with both hospital-grade systems and mobile devices, targeting signal distortions common in mobile, wearable, and dynamic clinical environments. This submission follows AIML's prior Device Master File (MAF) filing, which could facilitate future collaborations with manufacturers for device integration.

Additionally, AIML granted 800,000 stock options to directors and consultants at an exercise price of $0.105, vesting quarterly over one year with a five-year expiration.

Positive

• Submission of 510(k) premarket notification to FDA represents significant regulatory progress
• Prior Device Master File submission enables potential future collaborations with manufacturers
• Technology compatible with both hospital-grade systems and mobile devices, expanding market potential
• Platform addresses key market need for improved ECG signal quality in real-world conditions

Negative

• FDA approval not yet secured, representing regulatory uncertainty
• Stock option grants at $0.105 could lead to future dilution for existing shareholders

Proprietary neural network, cloud-based AI-powered technology designed to support clearer ECG signal interpretation across care settings.

TORONTO, ON / ACCESS Newswire / May 15, 2025 / AI/ML Innovations Inc. ("AIML" or the "Company") (CSE:AIML)(OTCQB:AIMLF)(FWB:42FB), a developer of AI-based signal processing technologies for healthcare, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its MaxYield™️platform.

MaxYield is a cloud-native API and file-processing solution designed to enhance the quality of electrocardiogram (ECG or EKG) signals across 1- to 12-lead configurations in adult patients aged 18 years and older. It applies a proprietary neural network algorithm to reduce noise and improve waveform clarity, with the goal of supporting more consistent ECG signal interpretation in clinical, ambulatory, and wearable monitoring environments.

MaxYield is designed for broad input compatibility, capable of processing data from both hospital-grade systems and mobile devices. The platform is part of AIML's strategy to enable seamless integration of signal optimization capabilities into emerging digital health ecosystems.

This regulatory milestone builds on AIML's prior submission of a Device Master File (MAF) to the FDA. If accepted, the MAF may support future collaborations with manufacturers interested in integrating MaxYield into their own cleared devices, subject to applicable regulatory requirements.

"MaxYield addresses one of the core challenges in digital health-delivering clearer ECG signals in noisy, real-world conditions," said Peter Kendall, President and Chief Commercial Officer of AIML. "This 510(k) submission marks an important step toward helping clinicians access better-quality ECG data in diverse care settings."

MaxYield targets signal distortions commonly seen in mobile, wearable, and dynamic clinical environments-such as motion artifacts, low-amplitude waveforms, baseline wander, and non-physiological noise. By improving signal fidelity, the platform aims to enhance clinician confidence in ECG review and downstream analysis tools.

AIML remains steadfast in its mission to deliver breakthrough solutions at the intersection of artificial intelligence and human health.

Stock Options
The Company also announces a grant of 800,000 stock options ("Options") under the Company's Stock Option Plan ("Plan) to certain directors and consultants of the Company to acquire up to an aggregate of 800,000 common shares in the capital of the Company. The Options were granted effective May 15, 2025 ("Grant Date") and are subject to the terms of the Plan, the applicable grant agreements and the requirements of the Canadian Securities Exchange. The Options were issued at an exercise price of $0.105, vest quarterly over one year and expire five years from the Grant Date.

For more information about AIML:
For detailed information please see AIML's website or the Company's filed documents at www.sedarplus.ca.

Contact:
Blake Fallis
(778) 405-0882
info@aiml-innovations.com

About AIML Innovations Inc.
www.aiml-innovations.com

AIML Innovations Inc. is a global technology company pioneering the use of artificial intelligence and neural networks to transform digital health. Our proprietary platforms leverage advanced signal processing and deep learning to convert complex biometric data into actionable clinical insights-supporting earlier diagnosis, personalized treatment, and more effective care.

With a growing portfolio of regulatory filings, including a 510(k) premarket notification and a registered FDA Device Master File, AIML is committed to rigorous validation and broad interoperability.

AIML's shares trade on the Canadian Securities Exchange (CSE:AIML), the OTCQB Venture Market (AIMLF), and the Frankfurt Stock Exchange (42FB).

On behalf of the Board of Directors:
Paul Duffy, Chairman

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.

Forward-Looking Statements - Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties, including risks associated with the implementation of the Company's products and services and any future review and/or approval of the Max Yield and/or Device Master File submissions by the FDA as currently proposed or at all. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company, including with respect to the nature and timing of future operations and the receipt of all applicable regulatory approvals. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements.

SOURCE: AI/ML Innovations, Inc.

View the original press release on ACCESS Newswire

FAQ

What is the status of AIML's MaxYield platform FDA approval?

AIML has submitted a 510(k) premarket notification to the FDA for MaxYield, but approval is still pending. The company has also previously submitted a Device Master File (MAF).

What does AIML's MaxYield platform do?

MaxYield is a cloud-native platform that enhances ECG signal quality using neural network algorithms. It reduces noise and improves waveform clarity in ECG signals across 1- to 12-lead configurations for adult patients.

How many stock options did AIML grant and at what price?

AIML granted 800,000 stock options to directors and consultants at an exercise price of $0.105, vesting quarterly over one year with a five-year expiration from May 15, 2025.

What are the key features of AIML's MaxYield platform?

MaxYield is compatible with both hospital-grade systems and mobile devices, processes data through a cloud-native API, and targets signal distortions common in mobile, wearable, and dynamic clinical environments.

What potential market applications does AIML's MaxYield platform have?

MaxYield can be integrated into clinical, ambulatory, and wearable monitoring environments, with potential for integration into other manufacturers' cleared devices through the Device Master File pathway.