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Letter to the FDA Urging the Agency Not to Approve the De Novo Premarket Application for neuroAD Therapy System for the Treatment of Alzheimer’s Dementia

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Public Citizen urged the Food and Drug Administration (FDA) not to approve the do novo premarket application for the neuroAD Therapy System from Neuronix as an adjunctive treatment of mild-to-moderate Alzheimer’s Dementia, because the data from the clinical trials demonstrated that the device does not offer any clinically meaningful benefits.

May 15, 2019, FDA acknowledgement letter.