CorTec receives second FDA Breakthrough Device Designation for Brain Interchange™

CorTec GmbH has received a second Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Brain Interchange™ system. This new designation specifically covers communication for individuals with non-progressive quadriplegia, allowing them to control computer cursors through thought alone.

The Brain Interchange™ platform is designed to address two distinct neurological needs using a single implant. As a therapeutic brain-computer interface (BCI), it stimulates the brain to aid stroke motor rehabilitation. As an assistive BCI, it decodes neural intentions to restore digital control and communication.

CorTec claims this makes them the only company in the BCI space with a designation for stroke motor rehabilitation. The company is currently conducting a stroke study at the University of Washington, where participants have already demonstrated the ability to control computers via thought using the implant.