China Approves World's First Commercial Brain Implant, Beating Musk

Expanding Presence in Neuroscience Neuracle's 'Neo' Wins First Approval 8 Sensors on Dura Collect Neural Signals Lower Risk of Bleeding and Tissue Damage Less Precise Than Neuralink Market Forecast to Grow 10-Fold in 10 Years U.S.-China Speed Race May Accelerate

International|
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By Lee Wan-ki
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null - Seoul Economic Daily International News from South Korea

A brain implant device connecting the brain and computer, known as a brain-computer interface (BCI), has entered the commercialization stage for the first time in the world in China. Having received approval from national regulators ahead of Neuralink, the company led by Elon Musk, China is seen as expanding its presence in brain science, following artificial intelligence (AI), humanoid robots, and quantum computers.

According to the New York Post and other outlets Friday, China's National Medical Products Administration (NMPA) recently approved a BCI device called "NEO," jointly developed by domestic startup NeuroXess Technology and researchers at Tsinghua University, as a product for patients paralyzed by spinal cord injuries. It marks the first time an invasive BCI device has received commercial approval from a national regulator.

BCI is a technology that converts brain signals into digital commands a computer can interpret. It is drawing attention as a next-generation field that can be used for the rehabilitation of patients with motor and speech disorders, as well as for treating various neurological diseases such as depression, epilepsy, stroke, and Parkinson's disease. According to market research firm Future Market Insights, the global market, currently worth around 490 million dollars, is projected to grow to 1.7 billion dollars by 2035.

NEO consists of a coin-sized central device and neural signal sensors placed over the dura mater. When eight sensors are surgically attached to the dura mater, the outer membrane that wraps and protects the brain, the neural signals they collect are transmitted to a computer through the device mounted on the skull. The computer then interprets the signals to control the movement of a robotic glove worn by the patient.

null - Seoul Economic Daily International News from South Korea

China's NEO is drawing particular attention because it represents an achievement faster than the brain implant device created by Musk's brain science startup Neuralink. Neuralink has been conducting clinical trials since 2024 but has yet to receive use approval from the U.S. Food and Drug Administration (FDA).

Experts believe the difference in the two companies' methods determined the speed of approval. Because NEO places its sensors over the dura mater, it does not touch brain tissue. By contrast, Neuralink's N1 chip penetrates the cerebral cortex directly to insert electrodes. The relatively less invasive Chinese method reduces the risk of bleeding or tissue damage, which was favorable for obtaining regulatory approval.

Support from the Chinese government also had an effect. China designated BCI as an industry to foster, along with quantum technology and humanoid robots, in its 15th Five-Year Plan, which takes effect this year. In particular, Chinese authorities laid the groundwork for distribution by including NEO in the national health insurance system immediately after approving it.

However, many assessments find it difficult to consider NEO's technology superior. While NEO's approach carries less risk, it is less precise than Neuralink, which reads signals directly from inside brain tissue. In effect, it focused on rapid distribution through lower risk rather than accuracy.

There are also points that NEO's scope of application is limited. NEO currently targets only patients aged 18 to 60 who have suffered spinal cord injuries but retain some arm function, giving it a smaller scope of application and narrower range of uses than Neuralink.

Still, experts forecast that this approval will intensify technological competition with the United States in the BCI field as well. In China, in addition to NEO, devices such as Beinao-1 are currently going through regulatory approval procedures. In the United States, along with Neuralink, companies such as Synchron are cited as leading players.

Amid the U.S.-China competition, concerns are also emerging that personal data protection and cybersecurity measures are being neglected. David Tuffley, a professor at Griffith University in Australia, pointed out, "BCI is indeed a very promising field, but there is a concern that it could allow hackers to access sensitive neural data."

Original reporting by Lee Wan-ki for Seoul Economic Daily.

AI-translated from Korean. Quotes from foreign sources are based on Korean-language reports and may not reflect exact original wording.

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