08:27 AM EDT, 09/25/2025 (MT Newswires) -- Helius Medical Technologies ( HSDT ) said Thursday it filed a 510(k) submission to the US Food and Drug Administration for its portable neuromodulation stimulator device, seeking a label expansion to cover an indication for gait and balance deficit in patients with chronic stroke symptoms.

The company said the submission was filed under its current FDA breakthrough device designation and includes data from its stroke registrational program.

The submission included data from three clinical trials that showed the device demonstrated "superior effectiveness in improving gait efficiency," Helius said.

The portable neuromodulation stimulator device delivers neurostimulation via a mouthpiece connected to a controller and is used along with physical rehabilitation exercises to improve balance and gait, the company said.

Shares of the company were down 6.7% in recent premarket activity.