Business
Helius Announces FDA 510(k) Submission for PoNS® Device Label Expansion in Stroke
Seeking an indication for gait and balance deficit in patients with chronic symptoms of stroke under its Breakthrough Device Designation NEWTOWN, Pa., Sept.
About this update from Solana Company
[{"type":"text","content":"Seeking an indication for gait and balance deficit in patients with chronic symptoms of stroke under its Breakthrough Device Designation\nNEWTOWN, 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 made with data generated in its Stroke Registrational Program (SRP) and was filed under its current FDA Breakthrough Device Designation. All statistical analyses for the Functional Gait Assessment (FGA) primary endpoint demonstrated PoNS superior effectiveness in improving gait deficit by achieving a clinically meaningful mean improvement of more than 5 points, which was statistically significant across all studies (p","length":1132,"tagName":"div"}]