---
title: "Helius Medical Seeks FDA Approval for PoNS Device"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/258903948.md"
description: "Helius Medical Technologies (HSDT) announced on September 25, 2025, that it has filed a 510(k) submission with the FDA for the PoNS device, seeking label expansion to treat gait and balance deficits in chronic stroke patients. The submission is backed by data from their Stroke Registrational Program. The company also granted one-time cash bonuses to its CEO and CFO. Analysts rate HSDT stock as a Hold with a $15.50 price target, but the company faces financial challenges, including declining revenue and negative profitability."
datetime: "2025-09-25T13:29:17.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/258903948.md)
  - [en](https://longbridge.com/en/news/258903948.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/258903948.md)
---

> Supported Languages: [简体中文](https://longbridge.com/zh-CN/news/258903948.md) | [繁體中文](https://longbridge.com/zh-HK/news/258903948.md)


# Helius Medical Seeks FDA Approval for PoNS Device

Helius Medical Technologies ( (HSDT) ) has issued an announcement.

On September 24, 2025, Helius Medical Technologies announced side letter agreements granting one-time cash bonuses to its CEO and CFO, which will offset any future severance or bonuses. On September 25, 2025, the company filed a 510(k) submission with the FDA for the PoNS device label expansion, seeking approval for treating gait and balance deficits in chronic stroke patients. The submission, supported by data from their Stroke Registrational Program, highlights PoNS’ superior effectiveness in improving gait deficits, which could significantly impact stroke rehabilitation and patient care.

The most recent analyst rating on (HSDT) stock is a Hold with a $15.50 price target. To see the full list of analyst forecasts on Helius Medical Technologies stock, see the HSDT Stock Forecast page.

**Spark’s Take on HSDT Stock**

According to Spark, TipRanks’ AI Analyst, HSDT is a Neutral.

Helius Medical Technologies faces significant financial challenges, with declining revenue and negative profitability being the most critical factors. While technical indicators show some positive momentum, the stock’s valuation is unattractive due to ongoing losses. The overall score reflects the company’s need to improve financial stability and operational efficiency.

To see Spark’s full report on HSDT stock, click here.

**More about Helius Medical Technologies**

Helius Medical Technologies is a leading neurotech company in the medical device field, focusing on neurologic deficits using an orally applied technology platform that enhances the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity. Their primary product is the Portable Neuromodulation Stimulator (PoNS), which is used to improve balance and gait in patients with neurologic diseases.

**Average Trading Volume:** 780,953

**Technical Sentiment Signal:** Strong Sell

**Current Market Cap:** $16.4M

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