Chinese startup Bonurcare has chosen a less invasive epidural method for brain‑computer interfaces (BCIs), placing electrodes just outside the dura mater. This compromise delivers solid signal quality while keeping safety risks low, and it has helped the company sail through China’s fast‑track medical‑device review process. Even so, domestic firms still trail U.S. leaders such as Neuralink and Blackrock Neurotech in core areas like chip fabrication, biocompatible materials, and long‑term implant stability. What gives China its current edge is not just technology but a supportive policy ecosystem. BCIs are listed as a strategic industry in the 15th Five‑Year Plan, and the national "Brain Science and Brain‑like Research" project mandates Class III device trials and registrations within its timeline. A special review program lets regulators evaluate innovative devices alongside development, preserving safety standards while accelerating approvals. Industry insiders say China’s temporary lead reflects efficient approvals, strong government backing, and rapid engineering progress. Companies like Zhuran Medical have already performed the world’s first human implantation of an ultra‑thin flexible deep‑brain electrode and launched multi‑center trials of wireless BCI systems—achievements on par with foreign rivals. Globally, the U.S. still dominates the pipeline, with several firms holding FDA Breakthrough Device designations, but none have secured full PMA approval yet. China’s early regulatory wins position it as the current front‑runner, though sustained leadership will depend on continued tech breakthroughs, robust clinical data, and the ability to set international standards.
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