Clearance covers the treatment of dynamic gait deficit due to chronic stroke symptoms. It expands the indications for PoNS beyond the existing approval for multiple sclerosis (MS). The milestone comes just a few months after Bioness acquired the PoNS technology in April.

PoNS expands the company’s L300 Go and H200 wireless functional electrical stimulation (FES) technology platform to include the non-invasive neuromodulation of the central nervous system, delivered via the tongue. The technology leverages the stimulation of selective cranial nerve pathways to promote neuroplasticity and functional recovery.