AI/ML Innovations Inc. (CSE:AIML) (OTCQB:AIMLF) (FWB:42FB) has announced the appointment of Dr. Mehmet A. Kosoglu, Ph.D., as Head of Regulatory at its wholly owned subsidiary, NeuralCloud Solutions Inc. The appointment is intended to support NeuralCloud’s regulatory work on its AI-powered cardiac technologies, including MaxYield™ and CardioYield™.
#Regulatory role at NeuralCloud
NeuralCloud is advancing ECG signal-processing technologies through validation, regulatory engagement and preparation for commercial deployment, according to the company. Dr. Kosoglu will support the regulatory strategy associated with those activities.
His background covers medical device development, biotechnology, FDA rules, Software as a Medical Device (SaMD), digital health, diagnostics, drug-device combination products and regulatory strategy. The company describes him as a former U.S. Food and Drug Administration lead reviewer and scientist with more than 15 years of relevant experience.
#Experience at the FDA and in industry
Dr. Kosoglu previously worked at the FDA’s Center for Devices and Radiological Health, where he served as a lead reviewer in the Office of Product Evaluation and Quality. His work included reviews involving 510(k)s, De Novo applications, investigational device exemptions, pre-submissions and PMA supplements.
He also worked at the FDA’s Center for Drug Evaluation and Research in the Office of New Drugs and its Biomarker Qualification Program. That work involved clinical trials, assay development, biomarkers, endpoints and scientific policy.
Beyond the FDA, the company says Dr. Kosoglu has held senior regulatory and product-development positions involving FDA discussions, verification and validation planning, preclinical and clinical study design, quality systems and market authorisation. His experience also includes FDA-regulated medical devices and digital health SaMD products.
#Appointment follows MDSAP certification
AI/ML Innovations said the appointment follows NeuralCloud’s achievement of ISO 13485:2016 Medical Device Single Audit Program (MDSAP) certification. The company describes the certification as the quality-management-system foundation for NeuralCloud’s regulated medical device development and commercialisation activities.
NeuralCloud develops artificial intelligence and neural-network technologies for ECG signal analysis and cardiac software applications. Its platforms are described as supporting ECG signal quality, waveform interpretation, arrhythmia analytics and clinical workflow efficiency in regulated healthcare settings.
#Regulatory status and stated risks
The announcement describes MaxYield™ and CardioYield™ as technologies being advanced through validation and regulatory engagement. It does not state that either product has received all applicable regulatory approvals.
The company cautioned that parts of the announcement contain forward-looking statements and substantial known and unknown risks. These include risks related to implementing its products and services as currently proposed or at all, the nature and timing of future operations, and the receipt of all applicable regulatory approvals. AI/ML Innovations also said the assumptions supporting such statements may prove imprecise.
#Key Takeaways
- NeuralCloud Solutions has appointed former FDA lead reviewer and scientist Dr. Mehmet A. Kosoglu, Ph.D., as Head of Regulatory.
- His experience includes medical devices, SaMD, digital health, diagnostics, biotechnology and FDA regulatory work.
- He will support regulatory activities for NeuralCloud’s AI-powered cardiac technologies, including MaxYield™ and CardioYield™.
- The appointment follows NeuralCloud’s ISO 13485:2016 MDSAP certification.
- The company says its technologies remain subject to validation, regulatory engagement and the receipt of applicable approvals.
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