FDA Clears Office Alzheimers Test System

A decade into its development and clinical testing, Neuronetrix has received U.S. FDA 510(k) clearance to market its Cognision™ System, bringing EEG and ERP testing to physician practices.

Background

Cognision is described as a proprietary and highly advanced platform which performs traditional EEG tests and a non-invasive test called auditory event-related potentials (ERP). These tests measure electrical signals produced by the brain and are often used by physicians to evaluate the kinds of cognitive deficits associated with Alzheimer’s disease and other dementias.

Complicated EEG tests have traditionally been performed in hospital electrophysiology labs by highly trained specialists. Contrastingly the company says the Cognision system is portable, easy-to-use and inexpensive enough to be used by private practice physicians in their office. Indeed the FDA’s clearance means these tests could now be performed during routine office visits by primary care physicians.

Neuronetrix says it will begin marketing the Cognision™ System to Alzheimer’s and memory disorder clinics and to physician practices which specialize in age-related dementias, a market projected to exceed several hundred million dollars per year in the U.S. alone.

Physician comments 

“Mobile neurodiagnostic devices offer great promise to enhance the objective assessment of a patients’ cognitive and neurological status at the point of care. Neural markers closely tied to cognitive status can also accelerate drug development for a variety of brain disorders” says Dr. Murali Doraiswamy, a leading expert in neurocognitive disorders at the Duke Institute for Brain Sciences and a scientific advisor to Neuronetrix.

Company comments 

“The effects of several drug compounds have already been successfully evaluated in well-controlled clinical studies using Cognision™. Now physicians will have access to that same technology in their own practices.” said Dr. Marco Cecchi, Director of Research and Clinical Affairs.

Source: PR Newswire

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