One day last October, sitting in the courtyard of his house in China's Henan province, Dong Hui decided to see if he could hold a pen to write. Dong, 39, had sustained spinal cord injuries in a car accident six years earlier that left him paralyzed from the neck down. Slowly but determinedly, he wrote his name, "Thank you," and then the date. This was the result of an 11-month-long rehabilitation enabled by an implant in his brain. Before that process, Dong could move his arms slightly but wasn't able to use his fingers. "I couldn't believe I was able to write again. I was so excited I even missed a stroke in my name," he told MIT Technology Review on a video call. In November 2024, Dong became one of the first people in China to be given an invasive brain-computer interface (BCI) through brain surgery. He had signed up for a clinical trial with the device's developer one month after seeing on TV how a BCI had apparently enabled another paralyzed Chinese man to hold his granddaughter. This March, the implant Dong uses became the first invasive BCI product in the world to be approved for use beyond clinical trials. It's now available to some patients with paralysis in their limbs due to spinal cord injuries. We spoke to a range of experts to understand why the device was able to reach this global milestone, what makes this moment so significant, and what to expect next.
The Big Picture
Dong's brain implant, called NEO, is a coin-size device developed by Neuracle Technology, a Shanghai-based startup, together with researchers at Tsinghua University in Beijing. During a procedure that took just over an hour and a half, the device's sensors, which collect Dong's brain signals, were placed on his dura mater, the tough outer layer of tissue that covers and protects the brain. The signals are transmitted to a computer by an implant placed on Dong's skull. The computer then translates the signals into commands for a soft robotic glove Dong wears during the 2.5-hour training sessions he completes each day to help him learn to grab. Dong started his rehabilitation around a week after surgery. "On the ninth day of my training, my right hand successfully grabbed a ball without the glove," he says. "That was a miraculous moment." Now he continues with his training at home. He wants to be able to control his hands better in order to put on clothes, eat, and do other daily tasks without troubling his aging parents.
“The approval of NEO marks the first time an invasive BCI has crossed the global regulatory finish line, beating competitors like Elon Musk's Neuralink.”
By the Numbers
- 36 clinical trials: Neuracle conducted 36 clinical trials using NEO since October 2023, with 32 of them taking place in just a few months in 2025.
- 4 first in-person trials: Details of the first four in-person trials were published in a preprint paper last July (2025).
- 11 months of rehab: Dong Hui underwent 11 months of rehabilitation with the implant before he could write his name.
- 2.5 hours daily: Dong trains 2.5 hours each day with the robotic glove to improve his grasping ability.
- 7 days post-surgery: Dong started rehabilitation one week after surgery, and on the ninth day he could grab a ball without the glove.
Why It Matters
The approval of NEO is not just a medical breakthrough; it's a geopolitical signal. China has placed the BCI industry on an expedited regulatory pathway, while the US FDA maintains a slower, more cautious process. This gives China a significant competitive advantage in commercializing brain-computer interface technology. NEO's "relatively less invasive" design—sensors placed on the dura mater rather than penetrating the cortex like Neuralink's N1 chip—reduces risks of hemorrhage, glial scarring, and long-term signal degradation, according to Avinash Singh, a BCI researcher at the University of Technology Sydney. This also eases regulatory approval. For investors, the lesson is clear: China's BCI ecosystem is maturing rapidly and could capture a large share of the global neurotechnology market, valued in the billions. Winners will be Chinese companies with government ties and manufacturing capabilities. Losers could be Western startups that rely on lengthy regulatory approvals.
What This Means For You
For investors, this milestone signals that the BCI sector is entering a phase of accelerated commercialization. China is willing to approve devices faster, which could yield early returns for those betting on Chinese neurotech firms. For patients with spinal cord injuries, especially in China, NEO offers a rehabilitation option that didn't exist before. However, cost and availability outside China remain uncertain. For Western competitors, the pressure is on: they need to speed up their own trials and seek faster regulatory pathways or risk falling behind.
- 1Investors: Consider diversifying into funds or ETFs that include Chinese BCI companies. NEO's approval could be the first of many products to hit the market from China.
- 2Patients and doctors: Stay informed about NEO's eligibility criteria (ages 18-60, limb paralysis from spinal cord injury with some residual arm function). It could be a viable option if you are in China.
- 3Tech companies: Evaluate partnerships with Neuracle or Tsinghua researchers. Collaborating with Chinese players may be key to accessing the Asian market.
What To Watch Next
The next milestone will be NEO's approval in other markets, such as Europe or the US. If Neuracle seeks global expansion, it will face stricter regulatory processes. Also watch for long-term outcomes from the 36 implanted patients, especially signal durability and quality of life. Neuralink, meanwhile, may accelerate its own trials to avoid losing ground. Additionally, the FDA's response to the Chinese approval could influence US regulatory policies. In the next 12 months, expect more news on BCI clinical trials in China and potential partnerships with hospitals abroad.
The Bottom Line
China's approval of NEO is a turning point in the global BCI race. It demonstrates not only that the technology is viable, but that a country can accelerate its adoption through supportive policies. For investors and healthcare professionals, the message is clear: the future of brain-computer interfaces is no longer a distant promise but an unfolding reality, with China in the lead. Watch Neuracle's next moves and the impact on global regulation.
