Neuralink PRIME trial: 21 patients across 4 countries — the largest cortical BCI program in history
Summary
The Neuralink PRIME (Precise Robotically Implanted Brain-Computer Interface) feasibility study enrolled 21 patients across the United States, United Kingdom, United Arab Emirates, and Canada as of mid-2026 — the largest active multi-national cortical BCI program in history. The N1 implant is inserted by the Neuralink R1 surgical robot, which drills the craniotomy and inserts the 64 electrode threads without human hand involvement. Five individuals with severe paralysis were reported to be actively using Neuralink to control digital devices as of June 2025. Enrollment target is 30 patients; a manuscript reporting primary PRIME results is anticipated in the New England Journal of Medicine.
Why it matters
Twenty-one patients across four countries enrolled in a cortical BCI feasibility study is a clinical program scale that no prior intracortical BCI has ever achieved. The multinational enrollment demonstrates that Neuralink's regulatory strategy extends beyond US FDA to MHRA (UK), UAE health authorities, and Health Canada simultaneously — building the international evidence base needed for eventual global commercial launch.
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