FDA Approves New Device for Cognitive Assessment

The FDA has approved Cerebral Assessment Systems Inc.’s Congnivue® device for US distribution. The novelty of the device forced the FDA to create a brand new sub-category of medical devices, designated “Cognitive Assessment Aids” (FDA Category: 882.1470). Congnivue is being marketed by the company as a unique, computer-based tool that can be used to better assess, measure, and monitor brain function for early signs of dementia. The device analyzes cognitive brain function by having the individual grasp a one-handed steering wheel, called a manipulandum, as he or she watches highlighted sections of an automated presentation of computer-generated displays. The patient moves the manipulandum to match with the highlighted areas, and the accuracy of the patient’s performance of this task provides a measure of their cognitive functioning. The approach has been termed “cognitive psychophysics”, which the company defines as “engaging patients in continuous stimulus-response paradigms that demand an intervening cognitive process.” The process allows physicians to monitor the patient’s focal cortical function as it relates to both the individual’s past performance as well as group standards, enabling the early recognition of declines in cognitive function. And because of the way it measures cognition, the Congnivue seems to be almost completely unobtrusive, with the patient’s only contact with the device being to touch the manipulandum.

The tests themselves do not diagnose Alzhiemer’s disease or other forms of dementia specifically, but instead serve as an inexpensive and effective means of early identification of cognitive decline. Likewise, the company claims that the product will enable physicians to provide more personalized care, catering treatment pathways to the specific circumstances of each individual patient.

The Congnivue can be administered in any exam room or office setting by trained healthcare professionals, including physician assistants, nurse practitioners, and other mid-level providers. This ease of access could change the way cognitive deficiencies are identified, says Cerebral Assessment Systems’ President and CEO Charles Duffy, MD, PhD. “The Congnivue is an important step forward in the detection and monitoring of cognitive decline,” says Dr. Duffy. “It is our bold goal to make cognitive function assessment as common as having your blood pressure checked at your annual physical.” More information can be found about the Congnivue and Cerebral Assessment Systems at https://www.cerebralassessmentsystems.com.  — Sean McGuire