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# FDA Wants More Info on Helius Technologies’ PoNS
- URL: https://www.fdaweb.com/fda-wants-more-info-on-helius-technologies-pons/
- Published: 2020-10-21T12:00:00.000Z
- Updated: 2026-09-14T16:33:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147925

FDA has asked Helius Medical Technologies for more information to support its request for *de novo* classification and clearance of the Portable Neuromodulation Stimulator device as a potential treatment for gait deficit due to symptoms of multiple sclerosis, intended to be used as an adjunct to a supervised therapeutic exercise program in patients over age 18\. Helius [says](https://heliusmedical.com/index.php/newsroom/news-release/2020/432-eliusedicalechnologiesncrovidespdateon20201019203200?ref=fdaweb.com) it submitted its *de novo* request to FDA 8/4 following the receipt of breakthrough designation in early May. It says the agency request for additional information includes requests for additional analysis of clinical data and proposes certain labeling modifications.

Company officials say they will respond as thoroughly and efficiently as possible.