CorTec's Brain Interchange earns a second FDA Breakthrough designation, for communication
After stroke rehabilitation, the implant is now recognized for helping people with quadriplegia control a computer cursor with brain signals.
German neurotech company CorTec has received a second FDA Breakthrough Device designation for its fully implanted Brain Interchange system. The new designation covers communication for people with non-progressive quadriplegia, letting them control a computer cursor with neural signals.
Two uses, one implant
The first designation covered stroke rehabilitation, using targeted brain stimulation to help recover arm movement. In April, a stroke participant in a University of Washington study used the same implant to play Pong by thought (our coverage). The new designation extends that “read” capability to people with paralysis.
According to the company, three patients have been implanted in the University of Washington stroke study, 13 have enrolled in an epilepsy study at Mayo Clinic, and a communication study for people with paralysis is planned at UMC Utrecht in the Netherlands.
Why it matters
Breakthrough designation doesn’t approve a device, but it gives faster, closer interaction with the FDA. CEO Frank Desiere noted that only a handful of BCI companies, including Neuralink and Paradromics, hold more than one such designation.
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