China's Brain-Computer Interface Milestone: First Invasive Medical Device Product Approved for Market Launch, Applicable to Spinal Cord Injury!

According to CCTV Finance, the National Medical Products Administration today approved the world’s first invasive brain-computer interface medical device for market launch, marking China’s first global debut in related clinical applications. A relevant official from the NMPA explained that this is a “globally new” product. “Globally new” specifically refers to a completely new drug or medical device that has not been marketed anywhere in the world.

This medical device is suitable for patients with spinal cord injuries and quadriplegia, assisting patients in regaining hand grasping functions. It is classified as a Class III medical device and is also the world’s first invasive brain-computer interface device to be approved for market launch, filling a gap in both international and domestic clinical applications and achieving a breakthrough from 0 to 1 in global invasive brain-computer interface medical devices.

The approved product was developed by Borui Kang Medical Technology (Shanghai) Co., Ltd. It uses an internationally pioneering minimally invasive extramedullary implantation and wireless energy communication technology to acquire brain signals without contact with brain tissue or damage to nerve cells, resulting in less trauma and more stable, reliable long-term use.

Following the announcement, related concept stocks in Hong Kong stocks immediately gained strength. Sanbo Brain Science, Innovation Medical, and Nanjing Panda all rose by over 10%, indicating a clear boost in market sentiment.

Large patient base for spinal cord injuries makes approval of brain-computer interface devices highly significant

Deputy Director of Neurosurgery at Huashan Hospital affiliated with Fudan University pointed out that currently, China has over 3.7 million patients with spinal cord injuries, with 90,000 new cases each year. The total number of patients worldwide has reached 15 million, with over 70% under the age of 50.

It is understood that spinal cord injury is considered a difficult-to-treat injury by the medical community. Most of these patients are high-level paraplegics and bedridden for many years. Especially for patients with a course of more than a year, neurological recovery is extremely difficult, and they are often referred to as “silent patients” in clinical practice.

Peng Liang, Deputy Director of the Medical Device Technical Review Center at the NMPA, stated that this medical device is called an Implantable Brain-Computer Interface Hand Motor Function Substitution System, suitable for patients with spinal cord injuries and quadriplegia, to assist patients in achieving hand grasping functions.

Peng Liang also emphasized that the most important feature of brain-computer interface medical devices is real-time reading and analysis of brain signals, interacting with external devices to achieve medical purposes. Brain-computer interface products without medical purposes do not belong to medical devices.

The NMPA clearly states that brain-computer interface medical devices are different from ordinary brain-computer interface products. They must possess the necessary core elements and be used for clinical treatment, undergoing strict approval by the drug supervision department.

National strategic backing and ongoing policy support

The approval of Borui Kang Medical is not an isolated event; behind it is the clear policy direction of the Chinese government to prioritize brain-computer interfaces as a key support area.

In the latest five-year plan, China has listed brain-computer interfaces as one of six future strategic industries, promising to accelerate regulatory approval processes and even develop medical insurance reimbursement guidelines before the products are officially launched. The goal is to cultivate brain-computer interface companies with a globally leading position by the end of this decade.

This policy environment has attracted significant capital inflows. Shanghai Step Medical Technology Co., Ltd. is one of the earliest domestic companies to initiate clinical trials of brain chips, with a technical route similar to Neuralink. This week, the company completed a 500 million RMB financing round led by Alibaba Group.

Additionally, Chengdu Gota Technology Co., Ltd. announced the completion of a 150 million RMB seed round of financing. The company’s technical development path is similar to that of Merge Labs, founded by Sam Altman.

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