Helius Medical Seeks FDA Approval for PoNS Device
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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.
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