‘Doctrine of the Mean’: how the US lost a 2-decade race to China in brain implants

For decades, the United States led the charge in the pursuit of brain-computer interface technology, betting big on bold, high-risk breakthroughs that promised to revolutionise medicine and human-machine integration. In the end, it is China crossing the finish line first. Using a semi-invasive approach that may lend credence to the Confucian “doctrine of the mean” – or the philosophy of seeking a middle path between extremes – a team in China has now come up with a commercially approved product ahead of all other players, including challengers in the US. Earlier this month, Shanghai-based Neuracle Medical Technology received a commercial-use approval for an implantable brain-computer interface (BCI) from China’s National Medical Products Administration. After decades of this technology being stuck in clinical trials globally, this feat makes their Neural Electronic Opportunity (Neo) implant the first invasive device in the world to be available outside trials. The development of BCI has been defined by a difficult trade-off: a non-invasive approach that sacrifices precision or an invasive approach that sacrifices safety. But in the global race to deploy commercial, high-performance BCIs, developers have faced challenges in balancing the superior performance of invasive approaches with long-term safety concerns. The Neo implant, designed to restore hand motor function in patients with spinal cord injuries, was developed in collaboration between Hong Bo’s team at Tsinghua University and Neuracle, which was founded by Tsinghua graduate Xu Honglai in 2011. BCIs are devices that record brain activity or electrical signals from neurons to guide outside devices, such as prosthetic limbs, wheelchairs or computer cursors. These systems aim to provide improved motor function for patients with impairments such as paralysis. In the early days of BCIs, there were two main developmental approaches. The first was non-invasive devices, where sensors are placed outside the scalp. These devices are safer but less accurate due to the physical barrier of the skull. The second is the invasive approach, used by Elon Musk’s Neuralink in their brain implant, which involves implanting sensors directly into the brain’s cerebral cortex. This method is more precise, but can have long-term challenges such as electrode displacement and biocompatibility issues. In 2013, Hong’s team at Tsinghua University pioneered a semi- or minimally invasive BCI approach where electrodes are placed onto the brain’s surface but do not penetrate it, according to a university statement on Wednesday. Many BCI developers have opted for a fully invasive approach, including US players such as Paradromics and Blackrock Neurotech, as well as Chinese firm NeuCyber’s Beinao-2. In contrast, others including US company Precision Neuroscience and NeuCyber’s Beinao-1 have embraced a semi-invasive approach. The challenges faced by Neuralink, the most visible player on the US market, have highlighted some of the safety barriers to commercialising an invasive approach. Around a month after the first patient received a Neuralink implant in 2024, they lost significant functionality after 85 per cent of the implanted electrode threads retracted or shifted out of position. Neuralink was able to tweak the system to respond to the remaining electrodes, though thread retraction remains a concern for long-term functionality. Neo has already been implanted into 32 patients with spinal cord injuries, all of whom achieved brain-controlled grasping using a robotic glove after surgery. Over two-thirds of the patients have even experienced a “significant improvement in their voluntary hand motor function scores after six months of brain-computer interface grasping training”, according to Tsinghua. “Approval for the market launch of medical devices does not mean that they can be used in hospitals immediately, but I believe that in the near future, more patients will be able to use brain-computer interface products designed and manufactured in China,” Hong said in the Tsinghua statement. The Neo device they created is a small, wirelessly powered implant that can reliably send recordings of brain signals, eliminating the need for traditional wires and avoiding the risks of battery failure. Compared with other implants, including those created by Neuralink and BrainGate – a research consortium that created one of the first BCIs in the early 2000s – Neo offers a new approach that balances performance and invasiveness, according to Tsinghua. Neo received approval for in-human studies in 2023, with the first patient receiving the implant in October of that year. Of the 32 patients who have received an implant, 22 have experienced a neural repair phenomenon in which their voluntary hand motor function improved. Hong’s team is doing more research on this phenomenon, according to Tsinghua. As of January, 21 participants had enrolled in Neuralink’s BCI trial. No invasive BCI devices have been approved for commercial use in the US yet. China has vowed to develop several global BCI competitors to compete with Neuralink, the main US player on the market. This year, BCI was listed as a future industry for the first time in the government’s work report alongside technologies such as quantum computing and embodied intelligence. Besides Neuracle, other Chinese BCI companies including Nanjing Panda Electronics and MicroPort NeuroScientific are also set to benefit from Beijing’s policies to prop up the BCI field and make breakthroughs by 2027. Other US players include Paradromics, Precision Neuroscience, Synchron, and Blackrock Neutrotech.

‘Doctrine of the Mean’: how the US lost a 2-decade race to China in brain implants

.css-1c6uqr6{color:inherit;font-weight:inherit;font-size:inherit;font-family:inherit;line-height:inherit;overflow-wrap:break-word;}China scores commercial-use approval for implantable brain-computer interface making it the first invasive device available outside trials

China scores commercial-use approval for implantable brain-computer interface making it the first invasive device available outside trials