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Nexalin Completes Successful Q-Submission Meeting with FDA for Alzheimer's Treatment Console.
ByAinvest
Wednesday, Dec 3, 2025 8:07 am ET1min read
Nexalin Technology, a leader in Deep Intracranial Frequency Stimulation (DIFS), has completed a Q-Submission meeting with the FDA regarding its Gen-2 SYNC neurostimulation console for Alzheimer's disease treatment. The FDA discussed the potential use of the De Novo classification pathway and provided a clear understanding of Nexalin's existing clinical data. The meeting focused on the company's proposed clinical development plan and overall regulatory strategy.
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