CorTec said on August 31 that FDA granted a second Breakthrough Device Designation to its Brain Interchange system. The new one covers communication for people with non-progressive quadriplegia, who would use the implant to move a computer cursor by thought. The April 2026 designation covered direct cortical stimulation for motor recovery after chronic stroke, a first for a brain computer interface.
Brain Interchange is a fully implantable wireless system that records cortical signals and stimulates in a closed loop. The same hardware does both jobs: stimulating to drive recovery, or decoding to drive a cursor. A participant in CorTec's stroke study at the University of Washington has already run a computer with it.
Two designations on one platform is a useful position for a company founded in 2010 that has yet to market a product. Brain Interchange also entered FDA's Total Product Life Cycle Advisory Program in April, which buys CorTec more of the agency's attention than a Breakthrough letter alone.