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RegulationJune 30, 2026

FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation

The FDA has cleared Bioness Medical's PoNS (Portable Neuromodulation Stimulator) system for stroke rehabilitation. The device uses neuromodulation to stimulate the trigeminal and facial cranial nerves, targeting improvement of gait impairment in stroke patients. The clearance expands the therapeutic applications available to rehabilitation providers and hospitals treating post-stroke motor dysfunction.

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