China Approves First Commercial Brain Implant as State-Backed Firm Trails Neuralink by Three Years

China became the first country in the world to approve an invasive brain-computer interface (BCI) medical device for commercial use last week, marking a significant milestone as Beijing races to expand clinical trials in the emerging neurotechnology sector. The approved device is a coin-sized wireless implant by Shanghai-based private firm Neuracle, which sits on the brain's outer membrane and controls a robotic glove, intended for patients with spinal cord injuries.

Despite this regulatory achievement, leading Chinese state-backed BCI startup NeuCyber Neurotech acknowledged that its most cutting-edge product is still three years behind Elon Musk's Neuralink. China is the second country to launch BCI human trials after the U.S.

"The benchmark for Beinao-2 is Neuralink. I have to say, (there is) about three years' lag because they have over 20 patients using it already," said the rotating CEO of NeuCyber, a startup affiliated with the Beijing-based Chinese Institute for Brain Research (CIBR). "We have just finished the first product and have to go through animal testing, then early-feasibility clinical trials, and then the real trials. That's maybe about two years later for the real trial."

NeuCyber's frontier Beinao-2 product is an invasive BCI with flexible electrodes that fully implant into the brain, currently undergoing large-scale animal implantation. Neuralink's technical advantage is that its surgical robot can insert hundreds of electrodes into the brain in minutes for its invasive N1 chip.

NeuCyber has achieved seven human implantations so far of the earlier Beinao-1, a semi-invasive BCI consisting of a mesh with electrodes implanted on the brain's outer membrane. Patients include quadriplegic car accident survivors who reported improvements in regaining hand motor function and could remotely control computer cursors after six months of use.

NeuCyber hopes to expand clinical trials of Beinao-1 to 50 patients this year, an important precursor to regulatory approval for commercial use. That could make Beinao-1 the brain chip with the highest number of patients in the world, underlining China's determination to catch up with leading foreign BCI developers. Neuralink, by contrast, has 21 participants enrolled in human clinical trials worldwide, the company said in January.

The startup estimates it could take two to three years before NeuCyber's BCI products could be commonly available on the domestic market, once they secure approval from China's health commission, medical insurance authorities and medical product regulators. "When we translate this into a real medical device, going through registration (for) large-scale trials, we will focus on motor function restoration for the spinal cord," the CEO said.

Beijing elevated BCIs to a core future strategic industry in its latest five-year plan, published this month, placing it alongside sectors such as quantum technology, embodied AI and nuclear fusion. The startup has received around 200 million yuan ($29 million) in funding from the Beijing government.