The N1 is Neuralink's first human-implantable BCI, a coin-sized device containing 1,024 electrodes distributed across 64 flexible polymer threads, each thinner than a human hair. The chip is implanted flush with the skull surface by the R1 surgical robot, which precisely inserts the threads into the motor cortex while avoiding surface vasculature. The N1 streams full-band neural signals wirelessly via Bluetooth Low Energy and is inductively recharged through the scalp. First implanted in a human on January 28, 2024, the device targets individuals with paralysis due to ALS or spinal cord injury, enabling computer cursor control and communication via decoded motor intent.
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.
FDA Device Regulatory Guidance ↗