FDA approves Investigational Device Exemption for Early Feasibility Study for rehabilitation of stroke patients using CorTec’s Closed-Loop Brain Interchangeimplant system.
CorTec has announced today that the US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application by the University of Washington School of Medicine (UW) involving the closed-loop Brain Interchange Implant System. This clinical study will investigate a novel stroke rehabilitation treatment using cortical stimulation to enhance plasticity within the brain. With the clearance of the Brain Interchange System for human use CorTec is prepared to serve clinicians and research groups with its advanced implant technology to investigate novel treatment options for neurological diseases.