China’s National Medical Products Administration has granted commercial approval to NEO, a coin-sized brain-computer interface (BCI) developed by Tsinghua University and Neuracle Technology.
This milestone marks the world’s first commercial authorization for an invasive brain implant designed to restore motor function outside research settings.
While Elon Musk’s Neuralink remains limited to human clinical trials, NEO secured rapid clearance due to a unique safety-first design. Instead of piercing the cerebral cortex, NEO’s eight sensors rest safely atop the dura mater, minimizing tissue damage and bleeding.
The narrow approval specifically applies to adults aged 18 to 60 suffering from full limb paralysis due to cervical spinal cord injuries who retain residual arm function.
During clinical trials across 11 hospitals, the system achieved a 100% success rate for home-based, brain-controlled grasp assistance.
By decoding intentions to power a robotic rehabilitation glove, patients independently performed daily tasks like eating and drinking.
