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# FDA Denies Helius De Novo App for Neuromodulation Stimulator
- URL: https://www.fdaweb.com/fda-denies-helius-de-novo-app-for-neuromodulation-stimulator/
- Published: 2019-04-10T12:00:00.000Z
- Updated: 2026-09-15T01:19:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143836

FDA has denied a Helius Medical Technologies *de novo* marketing request for its Portable Neuromodulation Stimulator (PoNS) device for treating patients with chronic balance deficit due to traumatic brain injury. In its rejection letter, the agency said there was not sufficient information to discern the relative independent contributions of the PoNS device and physical therapy on the improvements from baseline in the effectiveness endpoints observed in clinical studies, the company says. FDA told the company that it could generate additional data to address concerns and resubmit the application.

Helius says that FDA did not find any device-related serious adverse events in either of the two submitted clinical trials, and that patients in both the treatment and the sham control arms demonstrated improvements from baseline for all the pre-specified clinical endpoints, including the primary endpoint of responder rate based on a sensory organization test score. The company says it remains committed to generating the data to gain market clearance in the future.