QUANTITATIVE EEG MONITORS SHOULD BE USED ONLY AS ADJUNCT
This article was originally published in The Gray Sheet
Executive Summary
QUANTITATIVE EEG MONITORS SHOULD BE USED ONLY AS ADJUNCT to accepted methods of diagnosing mental, psychological, and other illnesses, FDA's Neurological Devices Advisory Panel concluded at a Sept. 16 meeting in Gaithersburg, Maryland. Although the panel did not vote on the issue, Panel Chairman Harold Wilkinson, PhD, MD, University of Massachusetts Medical Center, Worcester, summarized panel opposition to use of the devices in primary diagnosis in remarking that "there is great concern about any marketing that claims that any single device could give a clinical diagnosis."