CorTec Receives Second FDA Breakthrough Device Designation for Brain Interchange system
Shots:
- The US FDA has granted Breakthrough Device Designation to Brain Interchange system for communication in people with non-progressive quadriplegia, letting users to control a computer cursor through thought alone
- The new designation builds on Brain Interchange’s April 2026 BDD for stroke motor rehabilitation. The same implant can function therapeutically by stimulating the brain to support recovery or assistively by decoding brain signals to restore digital control
- CorTec is already demonstrating the tech in an ongoing stroke study at the University of Washington, where a participant used the implant to control a computer through thought. The company will now advance the communication application through structured FDA engagement
Ref: Cortec | Image: Cortec | Press Release
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