In March 2026, China’s National Medical Products Administration approved NEO, a brain-computer interface developed by Shanghai-based startup Neuracle Technology with researchers at Tsinghua University, for commercial use in patients with paralysis caused by spinal cord injuries. It is the first invasive BCI to clear a national regulator for use beyond clinical trials anywhere in the world. Neuralink has not yet reached that milestone. Neither has any other comparable device in the United States or Europe. Whether that constitutes a race won, or simply a different set of regulatory and engineering priorities, is a more complicated question than most coverage of this story has chosen to address. What the device actually does NEO is a coin-sized implant. During a procedure lasting approximately ninety minutes, the device’s eight sensors are placed on the dura mater, the tough fibrous membrane that covers and protects the brain. The sensors collect neural signals and transmit them to a computer via a unit mounted on the skull. The computer translates those signals into commands for a soft robotic glove worn during daily rehabilitation sessions. The distinction between placement on the dura mater and placement inside the cortex itself is not cosmetic. Neuralink’s N1 chip, by contrast, directly penetrates the cortex. According to Avinash Singh, a BCI researcher at the University of Technology Sydney quoted in MIT Technology Review , the epidural placement means NEO presents lower risk of haemorrhage, glial scarring, and long-term signal degradation. That lower risk profile almost certainly contributed to the pace of NEO’s regulatory clearance. The tradeoff is signal fidelity: electrodes sitting above the dura mater collect broader, less precise neural activity than electrodes inserted directly into cortical tissue. For the specific task NEO is currently approved to support, rehabilitating hand function in tetraplegic patients who retain some residual arm movement, that signal resolution appears to have been sufficient. The approved use is narrow: patients aged 18 to 60, with paralysis in all four limbs from spinal cord injuries, who retain some residual arm function. It is not a general movement restoration device. It is not approved for speech, vision, or broader motor control at this stage. The clinical record so far Since October 2023, Neuracle has conducted 36 clinical trials using NEO. Thirty-two of those took place across a few months in 2025. Details from one of the four initial trials were published in a preprint on medRxiv in July 2024. That preprint has not, to our knowledge, been published in a peer-reviewed journal as of this writing, and the results should be read as preliminary accordingly. The preprint documents a single case: a patient with complete C4 spinal cord injury who, after BCI-assisted rehabilitation, recovered the ability to perform grasping movements. Neuracle did not respond to a request for comment from MIT Technology Review , which conducted the reporting on which this piece is based. Wang Shouyan, a neuroscientist at Fudan University in Shanghai who was not involved in NEO’s research or trials, is quoted in the same reporting as describing the approval as significant for the BCI field more broadly, because most BCI development to this point has remained in laboratory settings. NEO’s commercial clearance represents a transition toward large-scale manufacturing and clinical deployment in China, Wang says. Why the regulatory timing diverged The pace of NEO’s approval reflects two factors operating together. The first is engineering: the epidural sensor placement put NEO into a lower-risk category than intracortical devices, reducing the regulatory burden Singh identifies. The second is policy: China placed BCIs on an expedited regulatory pathway and, days after NEO’s approval, incorporated the device into the national health insurance coding system as a first step toward patient co-payment coverage. China’s latest five-year plan, published on the same day Neuracle received its approval, lists BCI among six key industries targeted for national development, alongside quantum technology and humanoid robotics. The US Food and Drug Administration’s approval process for comparable devices typically takes several years longer, Singh notes. That gap is not simply bureaucratic friction; it reflects different frameworks for how much clinical evidence regulators require before permitting commercial use. Whether the Chinese framework is moving too quickly or the US framework too slowly is not a question the available evidence settles. Meicen Sun, an information scientist at the University of Illinois Urbana-Champaign who studies technology policy, makes a point worth holding on to: the US and Chinese BCI industries are pursuing different definitions of what the technology is for. The US approach has prioritised pushing the performance frontier, aiming for the highest-resolution neural interface possible. The Chinese approach, Sun argues, has oriented itself toward accessible deployment on a societal scale. Those are not competing paths toward the same destination. The comparison with Neuralink needs care Coverage framing this as China beating Neuralink to approval is not wrong, exactly, but it flattens what are substantively different engineering choices. NEO and Neuralink’s N1 chip are not attempting to do the same thing with identical methods, where one simply arrived first. NEO’s epidural sensors read aggregate cortical activity from above the protective membrane. Neuralink’s intracortical electrodes target individual neurons. The resolution gap is real. Higher resolution is potentially useful for more complex applications, including speech decoding or fine motor control in ways that broader epidural signals may not support at equivalent accuracy. The lower-invasiveness approach NEO has taken is not obviously superior; it is a different point on a tradeoff curve between signal fidelity and surgical risk. Whether that tradeoff was the right one for NEO’s specific application, rehabilitation assistance for spinal cord injury patients with residual arm function, is a narrower and more answerable question than whether epidural BCIs are generically better than intracortical ones. Scientists interviewed by MIT Technology Review specifically cautioned against framing US and Chinese BCI development as a race, noting that the implied endpoint of such a race is difficult to define. What to watch next Several other Chinese BCI candidates are in the domestic approval pipeline. One of them, Beinao-1, developed by the Chinese Institute for Brain Research and its affiliated startup NeuCyber NeuroTech, also uses dura mater placement and targets movement and speech difficulties caused by spinal cord injuries or amyotrophic lateral sclerosis. Singh estimates it could receive approval as early as 2028. Separately, the US company Axoft, based in Cambridge, Massachusetts, has disclosed trials of its own BCI in China in collaboration with a Chinese company and a Shanghai hospital. That the two countries’ BCI industries are collaborating at all, despite the current geopolitical climate, is the less-reported dimension of this story. For NEO specifically, the immediate question is how China’s health insurance reimbursement coding translates into actual patient access at scale. The device has a commercial approval; what it does not yet have is a clear picture of pricing, coverage rates, or how quickly hospitals can be equipped to perform the implantation procedure. The approval is the beginning of that process, not the end of it.

Source: Space Daily

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