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
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.