www.fdanews.com/articles/202100-fda-grants-de-novo-approval-for-multiple-sclerosis-gait-deficit-treatment
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FDA Grants De Novo Approval for Multiple Sclerosis Gait Deficit Treatment
March 30, 2021
The FDA has given Helius Medical’s Portable Neuromodulation Stimulator (PoNS) device De Novo authorization for short-term treatment of gait deficit due to multiple sclerosis.
The prescription-only device delivers neuromuscular electrical stimulation to the dorsal surface of the patient’s tongue to treat gait deficit caused by mild-to-moderate MS symptoms. It comes with a wearable mouthpiece and accompanying controller.
The system is now cleared for use in patients 22 years and older, but only as an adjunct to a supervised therapeutic exercise program.