FDA Approves Computer-Based Cognitive Assessment Tool

Cerebral Assessment Systems Inc. has received U.S. Food and Drug Administration (FDA) approval for its Cognivue cognition assessment tool.

Cognivue is touted as a first-of-its-kind computer-based tool that is designed to better assess, measure and monitor brain function to detect early signs of dementia. The assessment, which is reimbursable, can be conveniently administered in any exam room or primary care office by physician assistants, nurse practitioners and other mid-level providers.

The tool received de novo approval, creating a new class of FDA devices, designated Cognitive Assessment Aids (FDA Category: 882.1470), according to the company.

The Cognivue assessment is quick and non-invasive for the patient, and the equipment is affordable for physicians in independent practice as well as those affiliated with a medical group, Cerebral Assessment executives noted in a news release.

“The Cognivue is an important step forward in the detection and monitoring of cognitive decline,” said Charles Duffy, M.D. , Ph.D., Cognivue inventor and president/CEO of Cerebral Assessment Systems. “It is our goal to make cognitive function assessment as common as having your blood pressure checked at your annual physical.“

The de novo designation validates the need for the tool. Before the approval of Cognivue, most American doctors lacked a method to detect the early stages of cognitive decline and accurately measure treatment effectiveness, which has long been an obstacle to progress for dementia patients. Early detection of dementia using Cognivue will allow physicians to begin treatment earlier and monitor its effectiveness, company officials claim. More closely monitoring progress will allow physicians to halt ineffective treatments and begin a more optimal treatment plan.

“We know that cognitive decline is a primary concern of the 70 million Americans 65 years old or older. However, cognitive assessment is currently only available at academic medical centers in major cities,” said Duffy. “The Cognivue can bring such assessment to every corner of the country, making it as readily available as blood work. We forecast a tremendous market for the Cognivue, but we believe there is an even greater opportunity to make a difference in the lives of patients.”

The Cognivue tool stemmed from National Institutes of Health-funded basic research in cognitive neurology. The Cognivue is non-invasive and non-intrusive; the only direct contact with the patient is through their manipulation of a one-handed steering wheel called a manipulandum. The patient sits in front of a computer screen and watches an automated presentation of computer-generated displays with varying sections highlighted. The patient moves the manipulandum to indicate the highlighted location.

Cerebral Assessment Systems was founded in 2005 by Duffy, a researcher and professor in neurology, ophthalmology, neurobiology and brain and cognitive sciences at the University of Rochester Medical Center in Rochester, N.Y.