- AI/ML Innovations (AIML) has submitted a 510(k) premarket notification for its MaxYield™ platform to the FDA.
- The platform utilizes proprietary neural networks to enhance ECG signal quality for adult patients.
- AIML grants 800,000 stock options to directors and consultants, vesting quarterly over one year.
AI/ML Innovations Inc. (CSE:AIML) has made a significant regulatory move by submitting a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its MaxYield™ platform. This cloud-native solution is designed to enhance the quality of electrocardiogram (ECG) signals by reducing noise and improving waveform clarity through proprietary neural network algorithms. The platform is compatible with hospital-grade systems and mobile devices, supporting ECG signal quality across 1- to 12-lead configurations for adult patients aged 18 and older.
This regulatory submission follows AIML's earlier filing of a Device Master File (MAF) with the FDA. If accepted, the MAF could pave the way for future collaborations with manufacturers interested in integrating MaxYield into their cleared devices. By addressing common signal distortions in mobile, wearable, and dynamic clinical environments, the platform aims to support better clinical decision-making.
In addition to the regulatory filing, AIML has announced the grant of 800,000 stock options to directors and consultants. These options, issued at an exercise price of $0.105, will vest quarterly over one year and expire five years from the grant date of May 15, 2025. This stock option plan is part of the company's strategy to align its leadership team with shareholder interests and long-term company growth.
For more information, visit AIML's official website or consult the company's filed documents available on www.sedarplus.ca.
