The N1 is Neuralink's first human-implantable BCI, a coin-sized device (23mm x 18mm x 2mm) containing 1,024 electrodes distributed across 64 flexible polymer threads, each thinner than a human hair. The custom ASIC processes 200 Mbps of raw electrode data, compressing it ~200x for Bluetooth Low Energy transmission at ~1 Mbps. 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 and is inductively recharged through the scalp, achieving approximately 8 hours of operational life per charge. As of September 2025, 12 patients have received implants worldwide. Neuralink plans high-volume production and automated surgery in 2026.
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 ↗