Helius Medical Technologies’ Stroke Device Gets FDA Breakthrough Designation

Neurological device company Helius Medical Technologies has received the FDA’s Breakthrough Device designation for its PoNS device.

The device, which features a controller and mouthpiece that delivers electrical stimulation to the surface of the tongue, is intended as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke.

PoNS is meant to be used as an adjunct to a supervised therapeutic exercise program in stroke patients age 22 and up, according to the Newtown, Pa.-based company.