Regulatory Executive Brings More Than 15 Years of FDA, Medical Device, SaMD, and Digital Health Experience to Support AIML's Medical Device Strategy
TORONTO, ON / ACCESS Newswire / September 1, 2026 / AI/ML Innovations Inc. ("AIML" or the "Company") (CSE:AIML)(OTCQB:AIMLF)(FWB:42FB), a company advancing artificial intelligence and neural-network-based technologies for digital health, is pleased to announce that its wholly owned subsidiary, NeuralCloud Solutions Inc. ("NeuralCloud"), has appointed Dr. Mehmet A. Kosoglu, Ph.D., as Head of Regulatory.
Dr. Kosoglu is a former U.S. Food and Drug Administration ("FDA") lead reviewer and scientist with more than 15 years of experience spanning medical device development, biotechnology, FDA regulations, Software as a Medical Device ("SaMD"), digital health, diagnostics, drug-device combination products, and regulatory strategy. In his new role, Dr. Kosoglu will support NeuralCloud as the Company advances its regulatory strategy for its AI-powered cardiac technologies, including MaxYield and CardioYield.
Dr. Kosoglu's appointment strengthens NeuralCloud's regulatory leadership at an important stage in the Company's development, as NeuralCloud continues progressing its ECG signal-processing technologies through validation, regulatory engagement, and preparation for commercial deployment.
The appointment of Dr. Kosoglu follows our last regulatory milestone for the Company; the achievement of ISO 13485:2016 Medical Device Single Audit Program (MDSAP) certification, establishing the quality management system foundation supporting NeuralCloud's regulated medical device development and commercialization activities.
Paul Duffy, Executive Chairman and CEO of AIML, commented: "Dr. Kosoglu brings exactly the type of regulatory depth and FDA experience that AIML needs as we continue building NeuralCloud as a medical device software company. His background as a former FDA lead reviewer, combined with his direct experience guiding SaMD and digital health products through regulatory pathways, will be invaluable as we advance MaxYield, CardioYield, and our broader cardiac technology portfolio."
Dr. Kosoglu previously served at the FDA's Center for Devices and Radiological Health ("CDRH") as a Lead Reviewer in the Office of Product Evaluation and Quality (formerly known as the Office of Device Evaluation), where he led review teams for premarket submissions including 510(k)s, De Novo applications, investigational device exemptions ("IDEs"), pre-submissions, and PMA supplements. He also contributed to FDA guidance documents and helped establish regulatory policy and special controls for novel device categories.
In addition to his CDRH experience, Dr. Kosoglu served at the FDA's Center for Drug Evaluation and Research ("CDER") in the Office of New Drugs, Biomarker Qualification Program, where he worked on clinical trials, assay development, biomarkers, endpoints, and scientific policy. His combined device, drug, biomarker, and combination-product experience provides NeuralCloud with broad regulatory expertise across multiple areas relevant to AI-enabled healthcare technologies.
Dr. Kosoglu has also held senior regulatory and development roles in industry, where he led regulatory planning, FDA interactions, verification and validation planning, preclinical and clinical study design, quality-system development, and market authorization efforts. He has successfully introduced multiple FDA-regulated medical devices into the U.S. market, including Software as a Medical Device products, and has secured an FDA clearance for a digital health SaMD application.
Dr. Mehmet Kosoglu, Head of Regulatory at NeuralCloud, commented: "AIML and NeuralCloud are developing technologies at the intersection of artificial intelligence, cardiac signal processing, and regulated medical software. This is an area where strong regulatory strategy, disciplined validation, and clear quality-system execution are essential. I look forward to working with the AIML and NeuralCloud teams to support a rigorous regulatory pathway for technologies that have the potential to improve ECG analysis and cardiac care."
Dr. Kosoglu holds a Ph.D. in Mechanical Engineering from Virginia Tech, an M.S. in Mechanical Engineering from Lehigh University, and a B.S. in Mechanical Engineering from Istanbul Technical University. He is also an award-winning researcher, primary inventor on multiple patents, and has authored or contributed to peer-reviewed publications in medical device and biomedical engineering fields.
Esmat Naikyar, President of NeuralCloud Solutions Inc. and Chief Product Officer of AIML, added: "Regulatory strategy is not separate from product development; it shapes how we build, validate, document, and deploy medical software. Dr. Kosoglu's experience across FDA review, SaMD, quality systems, clinical study design, and product development will help ensure our technologies are advanced with the discipline required for regulated healthcare environments."
The Company believes Dr. Kosoglu's appointment further supports NeuralCloud's ongoing efforts to build the regulatory, clinical, and operational infrastructure required to develop and commercialize AI-powered medical device software.
About Dr. Mehmet Kosoglu
Dr. Mehmet A. Kosoglu, Ph.D., is a senior regulatory affairs executive and former FDA lead reviewer with more than 15 years of experience in medical devices, biotechnology, FDA regulations, SaMD, digital health, diagnostics, and combination products. During his FDA tenure, he worked within CDRH and CDER, conducting and leading reviews across 510(k), De Novo, IDE, pre-submission, biomarker, and scientific policy matters.
Dr. Kosoglu has led regulatory strategy and FDA submissions for multiple medical device and digital health companies, including SaMD products. He has successfully secured FDA clearance for a digital health SaMD application and has supported the development, registration, and regulatory planning of multiple FDA-regulated technologies. He holds Ph.D., M.S., and B.S. degrees in Mechanical Engineering and is an inventor on multiple patents.
About NeuralCloud Solutions Inc.
NeuralCloud Solutions Inc., a wholly owned subsidiary of AIML Innovations Inc., 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 healthcare environments.
About AI/ML 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.
AIML's shares trade on the Canadian Securities Exchange (CSE:AIML), the OTCQB Venture Market (AIMLF), and the Frankfurt Stock Exchange (42FB).
For detailed information please see AIML's website at https://www.aiml.health or the Company's filed documents at www.sedarplus.ca.
AIML Contact:
Paul Duffy, Executive Chairman and CEO
ask@aiml-innovations.com
416-941-8900
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 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:
https://www.accessnewswire.com/newsroom/en/publishing-and-media/ai%2fml-innovations-subsidiary-neuralcloud-appoints-former-fda-reviewer-dr.-me-1214496
