Helius Medical's Neuromodulation Stimulator Nabs FDA Breakthrough Tag

The FDA has granted Breakthrough Device Designation to Helius Medical Technologies Inc's HSDT PoNS device.
Related content: Benzinga's Full FDA Calendar.
The designation covers the device for use as a temporary treatment of dynamic gait and balance deficits due to stroke as an adjunct to a therapeutic exercise program in patients 22 years of age and over.
PoNS, a portable neuromodulation stimulator, is a non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the tongue's surface to treat gait deficit.
Price Action: HSDT shares are up 10.7% at $15.90 during the premarket session on the last check Tuesday.

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