MoveAgain combines an array implanted in the brain with neural decoding and wireless output. The array records activity associated with intended movement, and the system converts those signals into commands for an external device. Blackrock Neurotech said the design builds on years of human BCI research.
The FDA program can provide closer regulatory interaction and faster development and review. It is not market approval and does not by itself establish safety or effectiveness. The designation covered the full MoveAgain system, not a standalone high-density recording array.