China just beat Neuralink to market with the world's first approved brain implant
A Chinese brain-computer interface has become the first invasive implant in the world to receive full commercial approval — not a trial permit, but an actual product license. Shanghai-based Neuracle Technology's NEO device got the green light from China's NMPA regulator in March 2026, per Bloomberg. Neuralink, by comparison, has implanted chips in just three people in the US, all under experimental trial conditions.
The device
NEO is roughly coin-sized and takes about 90 minutes to implant. The key design difference from Neuralink: its eight sensors sit on the outer membrane of the brain (epidural), rather than punching into cortical tissue. That sidesteps the scarring risk that tends to degrade signal quality over time with penetrating electrodes. Signals are relayed to an external processor, which converts the patient's neural activity into commands for a robotic glove worn on the hand.
The case that's drawn the most attention is Dong Hui, a 39-year-old from Henan province who was paralyzed from the neck down after a car accident six years ago. He received the NEO implant in November 2024. Eleven months later, he could write with a pen — fingers that had been completely immobile since the accident.
The regulatory gap
MIT Technology Review details how NMPA ran an expedited "green corridor" approval process that took months rather than the years the FDA typically requires. China has designated BCI technology one of six strategic national priorities, alongside quantum computing, and state funding backed the trials. Neuracle ran those trials on 32 patients in 2025 before approval — a much larger cohort than Neuralink's three US participants, though long-term safety comparisons between the two approaches remain thin.
NEO is now integrated into China's national medical insurance system, with partial state coverage available to patients aged 18–60 with severe spinal cord injuries. That shift — from experimental curiosity to reimbursed medical product — is the real milestone here.
What it means outside China
NEO has no FDA clearance and no announced path to the US or UK market. The closest US equivalent is Precision Neuroscience, which received FDA 510(k) clearance in August 2025. Neuralink remains in early human trials.
The broader picture is a widening gap in regulatory speed. Beijing has decided it can absorb the risk of moving fast on this technology. Whether long-term real-world data validates that bet — or surfaces problems that slower Western review would have caught — is the question that the next few years will answer.
More devices are already queued behind NEO. NeuroXess and StairMed are developing competing implants in China, and the Beijing Brain Institute's Beinao-1 system is expected to reach market by 2028. The race is no longer theoretical.