AIML Hits Key Regulatory Benchmark with 510(k) Filing for MaxYield(TM) Signal Enhancement Platform
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.
AI/ML Innovations (AIML) ha presentato una notifica premarket 510(k) alla FDA per la sua piattaforma MaxYield™, una soluzione cloud-native progettata per migliorare la qualità del segnale ECG. La piattaforma utilizza algoritmi proprietari di reti neurali per ridurre il rumore e migliorare la chiarezza delle forme d'onda nei segnali ECG in configurazioni da 1 a 12 derivazioni per pazienti adulti di età pari o superiore a 18 anni.
MaxYield è compatibile sia con sistemi di livello ospedaliero sia con dispositivi mobili, affrontando le distorsioni del segnale comuni in ambienti clinici mobili, indossabili e dinamici. Questa presentazione segue la precedente registrazione del Device Master File (MAF) da parte di AIML, che potrebbe facilitare future collaborazioni con i produttori per l'integrazione del dispositivo.
Inoltre, AIML ha concesso 800.000 opzioni azionarie a direttori e consulenti con un prezzo di esercizio di $0,105, con maturazione trimestrale nell'arco di un anno e scadenza a cinque anni.
AI/ML Innovations (AIML) ha presentado una notificación premarket 510(k) a la FDA para su plataforma MaxYield™, una solución nativa en la nube diseñada para mejorar la calidad de la señal del ECG. La plataforma utiliza algoritmos propietarios de redes neuronales para reducir el ruido y mejorar la claridad de la forma de onda en señales ECG con configuraciones de 1 a 12 derivaciones para pacientes adultos de 18 años o más.
MaxYield es compatible tanto con sistemas de nivel hospitalario como con dispositivos móviles, enfocándose en las distorsiones de señal comunes en entornos clínicos móviles, portátiles y dinámicos. Esta presentación sigue la previa presentación del Device Master File (MAF) de AIML, que podría facilitar futuras colaboraciones con fabricantes para la integración del dispositivo.
Además, AIML otorgó 800,000 opciones sobre acciones a directores y consultores con un precio de ejercicio de $0.105, con adquisición trimestral durante un año y vencimiento a cinco años.
AI/ML Innovations (AIML)는 FDA에 MaxYield™ 플랫폼에 대한 510(k) 사전 판매 신고를 제출했습니다. 이 클라우드 네이티브 솔루션은 ECG 신호 품질 향상을 위해 설계되었으며, 독자적인 신경망 알고리즘을 사용하여 18세 이상 성인의 1~12유도 ECG 신호에서 잡음을 줄이고 파형 선명도를 개선합니다.
MaxYield는 병원급 시스템과 모바일 기기 모두와 호환되며, 모바일, 웨어러블 및 동적 임상 환경에서 흔히 발생하는 신호 왜곡을 목표로 합니다. 이번 제출은 AIML이 이전에 제출한 장치 마스터 파일(Device Master File, MAF)을 기반으로 하여, 제조업체와의 향후 기기 통합 협력을 용이하게 할 수 있습니다.
또한 AIML은 이사 및 컨설턴트에게 행사 가격 $0.105로 80만 주의 스톡 옵션을 부여했으며, 이는 1년 동안 분기별로 권리가 부여되고 5년 후 만료됩니다.
AI/ML Innovations (AIML) a soumis une notification précommerciale 510(k) à la FDA pour sa plateforme MaxYield™, une solution cloud-native conçue pour améliorer la qualité du signal ECG. La plateforme utilise des algorithmes propriétaires de réseaux neuronaux pour réduire le bruit et améliorer la clarté des formes d’onde des signaux ECG dans des configurations de 1 à 12 dérivations pour les patients adultes de 18 ans et plus.
MaxYield est compatible avec les systèmes hospitaliers et les appareils mobiles, ciblant les distorsions de signal courantes dans les environnements cliniques mobiles, portables et dynamiques. Cette soumission fait suite au dépôt antérieur du Device Master File (MAF) par AIML, ce qui pourrait faciliter de futures collaborations avec les fabricants pour l’intégration de dispositifs.
De plus, AIML a accordé 800 000 options d’achat d’actions à des administrateurs et consultants au prix d’exercice de 0,105 $, avec une acquisition trimestrielle sur un an et une expiration à cinq ans.
AI/ML Innovations (AIML) hat eine 510(k) Premarket-Benachrichtigung bei der FDA für seine MaxYield™ Plattform eingereicht, eine cloud-native Lösung zur Verbesserung der ECG-Signalqualität. Die Plattform verwendet proprietäre neuronale Netzwerkalgorithmen, um Rauschen zu reduzieren und die Wellenformklarheit bei ECG-Signalen mit 1- bis 12-Kanal-Konfigurationen für erwachsene Patienten ab 18 Jahren zu verbessern.
MaxYield ist sowohl mit Krankenhaus- als auch mit mobilen Systemen kompatibel und zielt auf Signalverzerrungen ab, die in mobilen, tragbaren und dynamischen klinischen Umgebungen häufig auftreten. Diese Einreichung folgt auf AIMLs vorherige Device Master File (MAF)-Einreichung, die zukünftige Kooperationen mit Herstellern zur Geräteintegration erleichtern könnte.
Darüber hinaus gewährte AIML 800.000 Aktienoptionen an Direktoren und Berater zu einem Ausübungspreis von 0,105 USD, mit vierteljährlicher Vesting über ein Jahr und einer Laufzeit von fünf Jahren.
- 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
- 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
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
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