NeuroSigma Wins CE Mark for Monarch eTNS System

Los Angeles, Calif-based NeuroSigma has been awarded CE mark approval for its Monarch eTNS System for the treatment of ADHD in adults and children age 7 and older.

The approval is the first for any non-drug treatment of ADHD in the EU, NeuroSigma says. It also covers the adjunctive treatment of major depressive disorder and epilepsy.

The device consists of a cellphone-size pulse generator and a single-use electric patch applied to the forehead.  Signals are transmitted through lead wires to the patch to stimulate the trigeminal nerve. The triggered nerve fibers then send signals to targeted brain regions and change the activity there. — Michael Cipriano