VALENCIA, Calif., June 29, 2026
Bioness Medical, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its PoNS® (Portable Neuromodulation Stimulator) System for the treatment of dynamic gait deficit resulting from chronic stroke symptoms. The milestone makes PoNS® the first FDA-cleared non-invasive, orally applied neuromodulation device for stroke rehabilitation, significantly expanding treatment options for the more than seven million Americans living with stroke-related walking disabilities. The regulatory clearance broadens the device’s existing indication beyond multiple sclerosis (MS) and is supported by strong clinical evidence from the Stroke Registrational Program (SRP), which demonstrated statistically significant and clinically meaningful improvements in walking ability when PoNS Therapy® was combined with physical rehabilitation. The latest approval highlights the growing role of non-invasive neurostimulation technologies in restoring mobility, promoting neuroplasticity, and improving long-term functional recovery for patients affected by neurological disorders.
FDA Clearance Supported by Strong Clinical Trial Evidence
The FDA’s 510(k) clearance is based on results from the comprehensive Stroke Registrational Program (SRP), consisting of three clinical studies involving 159 chronic stroke survivors across 10 leading rehabilitation centers in the United States and Canada. The studies evaluated the effectiveness of PoNS Therapy® combined with physical therapy compared with physical therapy alone over a 12-week treatment period, followed by an additional 12-week durability assessment. The primary endpoint measuring Functional Gait Assessment (FGA) demonstrated statistically significant superiority for patients receiving active PoNS therapy, with a clinically meaningful improvement of 5.37 points compared with 3.31 points for the control group.
Approximately 56.1% of patients treated with PoNS achieved substantial gait improvement, compared with only 11.1% receiving physical therapy alone, representing a 45.5% higher treatment response rate. Clinical benefits remained durable throughout the follow-up period, with nearly 90% of participants maintaining therapeutic improvements, while the device demonstrated a favorable safety profile with no treatment-related serious adverse events reported across the clinical program.
Innovative Neuromodulation Promotes Neuroplasticity and Recovery
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The PoNS® System introduces an innovative approach to neurological rehabilitation through non-invasive neuromodulation delivered via the tongue. Using a small oral mouthpiece, the prescription device delivers gentle electrical stimulation to branches of the trigeminal and facial cranial nerves, activating neural pathways connected to the brainstem. This targeted stimulation promotes neuroplasticity, enabling the brain to form new neural connections that compensate for damaged motor pathways following stroke.
Designed for home use under physician supervision, PoNS is used alongside structured physical rehabilitation exercises to maximize functional recovery. The system has already established clinical utility for patients with multiple sclerosis, and the expanded indication for chronic stroke rehabilitation further strengthens its role as an advanced neurorehabilitation technology capable of improving walking ability, restoring independence, and enhancing quality of life for patients recovering from neurological injury.
Expanding Advanced Neurorehabilitation for Stroke Patients
The FDA clearance represents a significant milestone for Bioness Medical’s expanding rehabilitation technology portfolio, which includes functional electrical stimulation (FES), robotic gait training, and neuromodulation platforms. Stroke remains one of the leading causes of long-term disability worldwide, with persistent gait impairment significantly affecting patient independence and healthcare costs. The availability of an FDA-cleared, prescription-based, home-use neuromodulation device provides clinicians with an innovative therapeutic option capable of complementing conventional rehabilitation while improving patient accessibility and long-term outcomes.
Supported by Medicare coverage and an expanding body of clinical evidence, PoNS® is positioned to become an important component of modern neurorehabilitation practice. The FDA clearance underscores the growing importance of non-invasive neuromodulation technologies in transforming stroke recovery, promoting functional mobility, and advancing evidence-based rehabilitation for millions of patients living with chronic neurological disabilities.
Source: Bioness Medical press release
