The Utah Intracortical Electrode Array (UIEA) is the gold-standard research BCI platform, in continuous use since the early 2000s and the basis for most landmark BCI demonstrations including BrainGate. Manufactured by Blackrock Neurotech (formerly Blackrock Microsystems), the array consists of 96 silicon needles arranged in a 10x10 grid (minus 4 corners), each 1–1.5mm long with a platinum or iridium oxide tip. The CerePort percutaneous connector passes through the skull and skin, connecting to external Cerebus or NeuroPort recording systems. The Utah Array has been implanted in over 30 research participants across multiple IDE-approved clinical studies.
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 ↗