CorTec’s Brain Interchange™ system has received a second Breakthrough Device Designation from the US Food and Drug Administration (FDA), this time for communication applications in people with non-progressive quadriplegia.
The designation covers the system’s potential to help people with paralysis in all four limbs control a computer cursor using brain signals.
The technology is designed to provide a direct communication channel with digital devices without requiring physical movement.
Brain Interchange previously received FDA Breakthrough Device Designation in April 2026 for stroke motor rehabilitation.
The same implantable system is being developed for both therapeutic and assistive applications.
For rehabilitation, it is designed to stimulate the brain to support motor recovery, while the communication application is intended to decode neural signals and translate a user’s intent into computer control.
The assistive application is being explored in an ongoing stroke study at the University of Washington, where a participant has used the implant to control a computer through thought.
The latest designation will support further development of the communication application through structured engagement with the FDA.
It also highlights the potential of implantable brain-computer interfaces (BCIs) to support multiple neurological applications using a single system.
