A cursor on a screen is a small thing, unless it is the only part of the world you can still move. The U.S. Food and Drug Administration (FDA) has granted our Brain Interchange™ system a second Breakthrough Device Designation, now covering communication: enabling people with non-progressive quadriplegia — paralysis in all four limbs — to control a computer cursor through thought alone, and with it a direct, independent channel to the digital world.
The new designation joins the one Brain Interchange received in April 2026 for stroke motor rehabilitation. It places CorTec among the small global group of BCI companies holding more than one FDA Breakthrough Device Designation — and, to our knowledge, the only one designated for stroke motor rehabilitation. Both apply to the same implant: as a therapeutic BCI, Brain Interchange stimulates the brain to drive recovery; as an assistive BCI, it decodes intention to restore control.
The promise is already visible in the clinic. In our ongoing stroke study at the University of Washington, a participant used the same implant to control a computer through thought — an early glimpse of the assistive capability the communication program will now develop under structured FDA engagement.
One implantable system, many neurological conditions: that is the premise behind Brain Interchange, and the FDA has now recognized its breakthrough potential in two of them.
Media support
MC Services AG — Katja Arnold, Dr. Johanna Kobler, Kaja Skorka
cortec@mc-services.eu
+49 (0)89 210 228-0
