INBRAIN's BCI is the world's first graphene-based brain-computer interface, featuring ultra-thin (10 micrometer) flexible electrodes that conform to the brain surface with micrometer-scale precision. Graphene's carbon-based composition enables 200x greater charge injection than metal electrodes without Faradaic degradation, supporting millions of stimulation pulses. The platform provides bidirectional, closed-loop neural decoding and modulation with up to 1,024 contacts. In first-in-human studies at Manchester Centre for Clinical Neurosciences, the device captured distinct high-gamma activity linked to different phonemes and differentiated healthy from cancerous brain tissue. FDA Breakthrough Device Designation was granted in 2023 for Parkinson's disease treatment.
FDA Breakthrough Device Designation provides more interactive communication with FDA during development and a priority review pathway. The device is still under investigation and not yet approved for commercial sale.
FDA Device Regulatory Guidance ↗