Panel Nixes CES Reclassification; Benefits Don’t Trump Lack of Data

Despite few safety risks, a sharply divided FDA advisory panel voted not to reclassify cranial electrotherapy stimulation (CES) devices from Class III to Class II because of a lack of data to support the products’ efficacy. The devices — used to treat depression, anxiety and insomnia by directing a mild electrical current through the brain — are widely used in the military to treat soldiers suffering from battle fatigue and other disorders.
Devices & Diagnostics Letter