Posted by Michael Wonder on 17 Aug 2021
Helius Medical Technologies announces FDA breakthrough device designation for the treatment of dynamic gait and balance deficits following a stroke
17 August 2021 - Helius Medical Technologies today announced that it has received breakthrough designation from the U.S. FDA for its PoNS device with the proposed indication for use as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke, to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over.
The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit.
