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鈩� 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鈩�, una soluzione cloud-native progettata per migliorare la qualit脿 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 et脿 pari o superiore a 18 anni.
MaxYield 猫 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 notificaci贸n premarket 510(k) a la FDA para su plataforma MaxYield鈩�, una soluci贸n nativa en la nube dise帽ada para mejorar la calidad de la se帽al del ECG. La plataforma utiliza algoritmos propietarios de redes neuronales para reducir el ruido y mejorar la claridad de la forma de onda en se帽ales ECG con configuraciones de 1 a 12 derivaciones para pacientes adultos de 18 a帽os o m谩s.
MaxYield es compatible tanto con sistemas de nivel hospitalario como con dispositivos m贸viles, enfoc谩ndose en las distorsiones de se帽al comunes en entornos cl铆nicos m贸viles, port谩tiles y din谩micos. Esta presentaci贸n sigue la previa presentaci贸n del Device Master File (MAF) de AIML, que podr铆a facilitar futuras colaboraciones con fabricantes para la integraci贸n del dispositivo.
Adem谩s, AIML otorg贸 800,000 opciones sobre acciones a directores y consultores con un precio de ejercicio de $0.105, con adquisici贸n trimestral durante un a帽o y vencimiento a cinco a帽os.
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MaxYield電� 氤戩洂旮� 鞁滌姢韰滉臣 氇皵鞚� 旮瓣赴 氇憪鞕� 順疙櫂霅橂┌, 氇皵鞚�, 鞗柎霟笖 氚� 霃欖爜 鞛勳儊 頇橁步鞐愳劀 頋旐瀳 氚滌儩頃橂姅 鞁犿樃 鞕滉场鞚� 氇╉憸搿� 頃╇媹雼�. 鞚措矆 鞝滌稖鞚� AIML鞚� 鞚挫爠鞐� 鞝滌稖頃� 鞛レ箻 毵堨姢韯� 韺岇澕(Device Master File, MAF)鞚� 旮半皹鞙茧 頃橃棳, 鞝滌“鞐呾泊鞕�鞚� 頄ロ泟 旮瓣赴 韱淀暕 順戨牓鞚� 鞖╈澊頃橁矊 頃� 靾� 鞛堨姷雼堧嫟.
霕愴暅 AIML鞚� 鞚挫偓 氚� 旎劋韯错姼鞐愱矊 頄夓偓 臧�瓴� $0.105搿� 80毵� 欤检潣 鞀ろ啞 鞓奠厴鞚� 攵�鞐枅鞙茧┌, 鞚措姅 1雲� 霃欖晥 攵勱赴氤勲 甓岆Μ臧� 攵�鞐悩瓿� 5雲� 頉� 毵岆霅╇媹雼�.
AI/ML Innovations (AIML) a soumis une notification pr茅commerciale 510(k) 脿 la FDA pour sa plateforme MaxYield鈩�, une solution cloud-native con莽ue pour am茅liorer la qualit茅 du signal ECG. La plateforme utilise des algorithmes propri茅taires de r茅seaux neuronaux pour r茅duire le bruit et am茅liorer la clart茅 des formes d鈥檕nde des signaux ECG dans des configurations de 1 脿 12 d茅rivations pour les patients adultes de 18 ans et plus.
MaxYield est compatible avec les syst猫mes hospitaliers et les appareils mobiles, ciblant les distorsions de signal courantes dans les environnements cliniques mobiles, portables et dynamiques. Cette soumission fait suite au d茅p么t ant茅rieur du Device Master File (MAF) par AIML, ce qui pourrait faciliter de futures collaborations avec les fabricants pour l鈥檌nt茅gration de dispositifs.
De plus, AIML a accord茅 800 000 options d鈥檃chat d鈥檃ctions 脿 des administrateurs et consultants au prix d鈥檈xercice de 0,105 $, avec une acquisition trimestrielle sur un an et une expiration 脿 cinq ans.
AI/ML Innovations (AIML) hat eine 510(k) Premarket-Benachrichtigung bei der FDA f眉r seine MaxYield鈩� Plattform eingereicht, eine cloud-native L枚sung zur Verbesserung der ECG-Signalqualit盲t. Die Plattform verwendet propriet盲re neuronale Netzwerkalgorithmen, um Rauschen zu reduzieren und die Wellenformklarheit bei ECG-Signalen mit 1- bis 12-Kanal-Konfigurationen f眉r 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 h盲ufig auftreten. Diese Einreichung folgt auf AIMLs vorherige Device Master File (MAF)-Einreichung, die zuk眉nftige Kooperationen mit Herstellern zur Ger盲teintegration erleichtern k枚nnte.
Dar眉ber hinaus gew盲hrte AIML 800.000 Aktienoptionen an Direktoren und Berater zu einem Aus眉bungspreis von 0,105 USD, mit viertelj盲hrlicher Vesting 眉ber ein Jahr und einer Laufzeit von f眉nf 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 / / 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鈩笍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 .
Contact:
Blake Fallis
(778) 405-0882
[email protected]
About AIML Innovations Inc.
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.
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