Neuracle's NEO brain implant wins China approval before Neuralink

Why it matters

Neuracle's approval turns invasive BCIs from a lab and trial story into a regulated medical product story, while giving China an early lead in a field long defined by U.S. attention around Neuralink.

Neuracle Technology's NEO brain-computer interface became the first invasive BCI product approved for use beyond clinical trials, MIT Technology Review reported, giving the Shanghai startup a regulatory milestone ahead of better-known rivals including Neuralink.

The approval, granted in March by China's National Medical Products Administration, is not a broad green light for brain implants. According to MIT Technology Review, NEO is cleared for patients ages 18 to 60 who have paralysis in all limbs from spinal cord injuries but retain some residual arm function.

The human case behind the approval is Dong Hui, a 39-year-old in Henan province who was paralyzed from the neck down after a car accident six years earlier. Dong received the implant in November 2024 through a clinical trial after seeing a TV segment in which another paralyzed Chinese man appeared to hold his granddaughter with help from a BCI. Before NEO, Dong could move his arms slightly but could not use his fingers.

A lower-risk route to the brain

NEO was developed by Neuracle Technology with researchers at Tsinghua University in Beijing. In Dong's surgery, which MIT Technology Review said took just over an hour and a half, the device's sensors were placed on the dura mater, the protective outer tissue covering the brain. A skull-mounted implant transmits brain signals to a computer, which translates them into commands for a soft robotic glove used during rehabilitation.

That design matters because NEO is invasive, but not in the same way as devices that penetrate the cortex. Avinash Singh, a BCI researcher at the University of Technology Sydney, told MIT Technology Review that NEO's sensors sitting on top of the brain's protective membrane could mean fewer regulatory concerns than a system such as Neuralink's N1 implant, which is designed to enter brain tissue.

That distinction is likely part of why Neuracle moved first. The device is still implanted through brain surgery, but MIT Technology Review's reporting points to a strategy built around a narrower medical claim, a defined patient population and a less invasive sensor placement.

The work happens after surgery

Dong's recovery also shows what the approval does not mean. The implant did not simply restore hand function on its own. Dong began rehabilitation about a week after surgery and trains for 2.5 hours a day, according to MIT Technology Review.

"On the ninth day of my training, my right hand successfully grabbed a ball without the glove," Dong told the publication. "That was a miraculous moment."

After 11 months of rehabilitation, Dong was able to hold a pen in his courtyard and write his name, "Thank you," and the date. He told MIT Technology Review he wants better control of his hands so he can dress, eat and handle daily tasks without relying as much on his aging parents.

Neuracle has conducted 36 clinical trials using NEO since October 2023, according to MIT Technology Review. Thirty-two of those took place over a few months in 2025, while details from one of the first four in-person trials were published in a preprint last July. The source material does not provide full trial outcomes, adverse event data or long-term durability results, all of which will matter as NEO moves from controlled trials into broader clinical use.

China is turning BCIs into an industrial bet

The timing is not incidental. Days after the NEO approval, China began assigning the device a unique code in its health insurance system, according to MIT Technology Review. That is an early step toward letting eligible patients pay a covered portion of the device's cost during treatment.

China's latest five-year plan, published the same day Neuracle received approval, lists brain-computer interfaces as one of six industries tied to the country's future tech competitiveness, alongside quantum technology and humanoid robots. Other Chinese BCI companies, including NeuroXess and StairMed, are also working in the field.

The approval shifts the comparison with Neuralink, the California BCI company founded by Elon Musk (@elonmusk), away from public attention and toward regulatory execution. Neuralink remains the more visible name globally, but Neuracle now has something the field has long lacked: an approved invasive BCI product with a defined clinical use case.

The unanswered questions are still substantial. Neuracle's funding, valuation, ownership and leadership were not included in the source material. More importantly for patients and physicians, the publicly available details in the provided reporting do not yet establish how NEO performs across larger groups, how durable the signal quality is over years, or how often complications occur.

For Dong, the milestone is already concrete. "Now, it will be able to help not only me, but also thousands and thousands of other patients suffering from spinal cord injuries in China who are tortured by despair each day," he told MIT Technology Review. "It will bring them hope and change their lives."