FDA Grants De Novo Approval for Multiple Sclerosis Gait Deficit Treatment

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.