CorTec Receives FDA Breakthrough Device Designation for Brain Interchange™ System in Stroke Rehabilitation

CorTec GmbH has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its Brain Interchange™ system. 

The designation applies to the use of direct cortical electrical stimulation to support motor recovery in individuals with chronic stroke-related impairments.

The FDA Breakthrough Device programme is intended for technologies with the potential to address life-threatening or irreversibly debilitating conditions and provides enhanced interaction and prioritised review during development.

The Brain Interchange system combines neural signal recording with adaptive, closed-loop stimulation, enabling bidirectional communication with the brain. 

The platform is currently under evaluation in an FDA-approved investigational device exemption (IDE) study at the University of Washington, representing the first clinical investigation of a fully implantable, wireless BCI system for stroke rehabilitation.

Stroke remains a leading cause of long-term disability, with a high proportion of patients experiencing persistent upper-limb motor impairment despite conventional rehabilitation. No approved implantable therapies currently exist for chronic stroke patients with plateaued recovery.

According to CorTec, the designation supports further clinical development and regulatory engagement as the company advances toward larger-scale trials. 

The Brain Interchange platform is also being explored for additional neurological indications, including epilepsy, paralysis, and depression.