CorTec Receives FDA Breakthrough Designation for Stroke Rehabilitation BCI
CorTec has received the FDA's Breakthrough Device Designation for its Brain Interchange system, a brain-computer interface (BCI) designed to support motor recovery in stroke patients. This designation applies to the use of direct cortical electrical stimulation to treat chronic stroke-related impairments, marking the first BCI globally to receive this recognition specifically for stroke motor rehabilitation. The system combines neural signal recording with adaptive stimulation in a closed-loop architecture, aimed at restoring motor function. It is currently being evaluated in an FDA-approved study at the University of Washington.