Mr. Paul Duffy reports

AI/ML INNOVATIONS' SUBSIDIARY NEURALCLOUD ACHIEVES ISO 13485:2016 (MDSAP) CERTIFICATION

AI-ML Innovations Inc.'s wholly owned subsidiary, NeuralCloud Solutions Inc., has achieved ISO 13485:2016 certification under the Medical Device Single Audit Program (MDSAP) for its quality management system.

The certification, issued by TUV USA Inc., applies to NeuralCloud's quality management system for the design, development, production and distribution of software as a medical device (SaMD) for ECG (electrocardiogram) analysis, including advanced PQRST waveform delineation, interval computation, arrhythmia analytics, signal quality scoring and artifact reporting.

ISO 13485 is the internationally recognized quality management system standard for medical devices, while MDSAP is a global regulatory audit program that allows a single audit of a medical device manufacturer's quality management system to support requirements across multiple participating regulatory jurisdictions.

For NeuralCloud, certification under ISO 13485:2016 (MDSAP) establishes an audited quality framework to support the company's continuing regulatory, clinical and commercialization activities for its ECG-focused SaMD technologies, including MaxYield and CardioYield.

"This certification is significant for NeuralCloud," said Esmat Naikyar, president of NeuralCloud Solutions and chief product officer of AI-ML. "Building advanced AI [artificial intelligence] for cardiac signal interpretation is only one part of becoming a true medical device company. Equally important is having the quality system, documentation, controls and audit readiness required to support safe, reliable and regulated medical software. Achieving ISO 13485:2016 (MDSAP) certification demonstrates that NeuralCloud has built that foundation."

Why MDSAP matters

For NeuralCloud, ISO 13485:2016 (MDSAP) certification is an important part of the company's regulatory-readiness strategy. MDSAP allows a recognized auditing organization to conduct a single quality management system audit that can be used by multiple participating regulatory authorities, reducing the total audit and inspection burden that multimarket medical device manufacturers may otherwise face. The program is designed to satisfy quality-system requirements across participating jurisdictions, including Canada, the United States, Australia, Brazil and Japan, while supporting greater consistency, predictability and transparency in medical device oversight.

One of the key practical benefits of MDSAP is that a single, recognized audit cycle can support continuing quality-system surveillance expectations across multiple jurisdictions. In the United States, participation in MDSAP is voluntary; however, the FDA (U.S. Food and Drug Administration) has stated that it will accept MDSAP audit reports as a substitute for routine FDA inspections, helping reduce duplicative routine inspection activity for certified manufacturers. In Canada, MDSAP is mandatory for a medical device licence and certification is a key requirement for manufacturers seeking Class II, Class III or Class IV medical device licences. Accordingly, NeuralCloud believes this certification strengthens its position as it advances its medical device strategy and prepares for future regulatory submissions and market opportunities.

While MDSAP supports quality-system regulatory readiness, it does not itself constitute product clearance or marketing authorization, nor does it replace applicable premarket review requirements. The FDA also retains authority to conduct inspections when required, including for-cause inspections related to complaints, recalls, adverse events or other regulatory concerns.

"This is an important step in AI-ML and NeuralCloud's regulatory-readiness strategy," said Paul Duffy, executive chairman and chief executive officer of AI-ML. "It reflects the company's commitment to building not only innovative technology, but the regulated infrastructure required to bring that technology into clinical use. As we advance our medical device strategy, this certification strengthens our ability to engage regulators, clinical partners, health care systems and commercial customers with confidence."

The certification supports NeuralCloud's broader strategy to deliver scalable AI-powered cardiac diagnostics across clinical, remote monitoring, telehealth, OEM (original equipment manufacturing) and research environments. NeuralCloud's ECG software platforms are designed to transform raw cardiac signals into structured, clinically useful outputs that support faster interpretation, improved workflow efficiency and broader access to high-quality cardiac insights.

About NeuralCloud Solutions Inc.

NeuralCloud Solutions, a wholly owned subsidiary of AI-ML Innovations, develops artificial intelligence and neural-network-based technologies for ECG signal analysis and cardiac software applications. Its platforms are designed to enhance ECG signal quality, support advanced waveform interpretation, enable arrhythmia analytics, and improve clinical workflow efficiency across regulated health care environments.

About AI-ML Innovations Inc.

AI-ML is a global technology company pioneering the use of artificial intelligence and neural networks to transform digital health. The company's 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.

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

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