Non-invasive Neurostimulation Device Wins FDA’s Breakthrough Status

Non-invasive Neurostimulation Device Wins FDA’s Breakthrough Status

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Non-invasive Neurostimulation Device Wins FDA’s Breakthrough Status

Cognito Therapeutic’s neurostimulation device — a next-generation digital therapeutic designed to treat memory and cognition symptoms in Alzheimer’s disease — has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA). The device, part of a new class of disease-modifying digital therapies, uses proprietary, non-invasive neurostimulation technology developed by Massachusetts Institute of Technology professors. “I am encouraged by Cognito’s innovative approach,” Allan Levey, MD, PhD, professor and chairman of the department…

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