Bioness Medical Announces 510(k) Clearance for PoNS® (Portable Neuromodulation Stimulator) to Manage Patients Recovering from Stroke
Bioness Medical has received FDA 510(k) clearance for its PoNS system, a non-invasive neuromodulation device designed to treat gait deficits in stroke patients. Clinical trials showed the device significantly improves walking ability when combined with physical therapy.
Why it matters
This approval offers a new technological pathway for neuro-rehabilitation, potentially improving long-term recovery outcomes for stroke survivors.
VALENCIA, Calif. , June 29, 2026 /PRNewswire/ -- Bioness Medical, Inc. ("Bioness", or the "Company"), a global leader in functional electrical stimulation (FES) and advanced rehabilitation technologies, today announced that the Company's PoNS ® (Portable Neuromodulation Stimulator) System has received FDA 510(k) clearance for the treatment of dynamic gait deficit due to chronic stroke symptoms. This clearance is supported by the Stroke Registrational Program (SRP), a three-study, 159-patient program at 10 centers of excellence in the U.S. and Canada, which demonstrated a sustained, statistically significant, and clinically meaningful improvement in dynamic gait deficit versus physical therapy (PT) alone, with a favorable safety profile, across all studies.
The text reports on regulatory approval and clinical trial results using industry-standard terminology.
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