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# Helius Neuromodulation Stimulator De Novo Submission
- URL: https://www.fdaweb.com/helius-neuromodulation-stimulator-de-novo-submission/
- Published: 2018-09-04T12:00:00.000Z
- Updated: 2026-09-15T00:29:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142259

Helius Medical Technologies has submitted a *de novo* clearance request for its Portable Neuromodulation Stimulator (PoNS) device for treating chronic balance deficit due to mild-to-moderate traumatic brain injury. The submission is supported by clinical data from two double-blind, randomized, controlled trials demonstrating the PoNS device’s safety and efficacy, with a combined enrollment of 163 patients, according to the company. The device, if granted clearance, would be the first tongue-delivered neuromodulation therapy that combines stimulation of cranial nerves with physical and cognitive therapy to restore lost neurological function, it says.