BrainGate is a research consortium comprising Brown University, Stanford University, Case Western Reserve University, and Massachusetts General Hospital, running the world's longest-duration human intracortical BCI study. The BrainGate2 trial uses Blackrock Utah Array electrodes implanted in motor cortex to record neural signals for communication and motor control. Key milestones include the first demonstration of a tetraplegic patient controlling a robotic arm for self-feeding, wireless BCI transmission, and high-speed typing by imagined handwriting. The program is led by Leigh Hochberg (MGH/Brown) and has enrolled more than 30 participants.
An IDE permits a device to be used in a clinical study to collect safety and effectiveness data required for a PMA or 510(k) submission. IDE devices are not approved for commercial sale.
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