China's NEO brain-computer interface gets commercial approval, world's first invasive BCI to receive regulatory approval ahead of Neuralink

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China’s National Medical Products Administration approved in March 2026 the commercial use of NEO, an invasive brain-computer interface developed by Shanghai startup Neuracle Technology in collaboration with Tsinghua University, making it the first invasive brain-computer interface to pass regulatory approval for market launch worldwide, surpassing competitors like Neuralink’s N1 to reach this milestone. NEO is a coin-sized device whose eight sensors are placed on the dura mater (the brain’s outermost protective membrane) without penetrating the cortex — unlike Neuralink’s N1, which directly pierces the cortex — and a sub-implant in the skull wirelessly transmits brain signals to a computer, which then translates them into commands for a soft robotic glove. The approved indications cover patients aged 18 to 60 who have quadriplegia due to spinal cord injury but retain partial residual upper limb function. Dong Hui (39) of Henan Province, who was completely paralyzed from the neck down after a car accident six years ago, became one of the first Chinese subjects in November 2024. After 11 months of rehabilitation training, he rewrote his name and the words „thank you