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Helius Announces FDA 510(k) Submission for PoNS® Device Label Expansion in Stroke
Globenewswire· 2025-09-25 11:00
Seeking an indication for gait and balance deficit in patients with chronic symptoms of stroke under its Breakthrough Device DesignationNEWTOWN, Pa., Sept. 25, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ: HSDT), today announced the filing of its U.S. Food and Drug Administration (FDA) 510(k) submission for the PoNS (Portable Neuromodulation Stimulator) device label expansion seeking an indication for gait and balance deficit in patients with chronic stroke symptoms. The submission was ...