Milestone moment for brain-computer interface in China: The first invasive medical device product approved for market, applicable to spinal cord injuries!

``` According to a report from CCTV Finance, the National Medical Products Administration (NMPA) today approved the world’s first invasive brain-computer interface (BCI) medical device for market release, marking China as the first globally in relevant clinical applications. An official from the NMPA stated that this is a "global first" product. "Global first" specifically refers to brand new pharmaceuticals or medical devices that have never been launched anywhere in the world. This medical device is intended for limb paralysis patients with spinal cord injuries, helping patients achieve hand grasp function. It is classified as a Category III medical device and is the world's first invasive BCI medical device to be marketed, filling a clinical gap both internationally and domestically, marking a breakthrough from zero to one in invasive BCI medical devices globally. The approved product was developed by BrainCo Medical Technology (Shanghai) Co., Ltd., using the world’s first extradural minimally invasive implantation and wireless power transmission technology. It acquires EEG signals without contacting brain tissue or damaging nerve cells, resulting in minor trauma and relatively stable and reliable long-term use. After the news was announced, related concept stocks in the Hong Kong market surged. Sanbo Brain Hospital, Innovation Medical, and Nanjing Panda each rose by over 10%, with a clear upturn in market sentiment. Large Population of Spinal Cord Injury Patients, Strict Approval for BCI Medical Devices The deputy director of the Department of Neurosurgery at Huashan Hospital affiliated to Fudan University pointed out that currently, the number of spinal cord injury patients in China has exceeded 3.7 million, with an additional 90,000 new cases each year. The cumulative number of cases worldwide has reached 15 million, and more than 70% of the patients are under 50 years old. It is understood that spinal cord injuries are regarded by the medical community as difficult to treat. Most of these patients suffer from high-level paralysis and are bedridden for years. Especially for those with illness duration beyond one year, neural function rehabilitation is extremely challenging, and they are often referred to clinically as "silent patients." Peng Liang, deputy director of the First Review Department of the Center for Medical Device Evaluation at the NMPA, stated that the device is called an implantable brain-computer interface hand movement function compensation system. It is suitable for limb paralysis patients with spinal cord injuries and helps patients achieve hand grasp function. Peng Liang also noted that the most important feature of BCI medical devices is the real-time reading and analysis of brain signals, and their interaction with external devices for medical purposes. BCI products without medical applications are not classified as medical devices. The NMPA clearly emphasized that BCI medical devices differ from regular BCI products. They must possess core elements for clinical treatment and undergo stringent approval by medical supervisory authorities. National Strategy Endorsement, Continued Policy Support The approval of BrainCo Medical is not an isolated incident; it is backed by clear policy directives from the Chinese government designating BCI as a key support sector. In the latest Five-Year Plan, China listed BCI as one of six future strategic industries and pledged to accelerate regulatory approval processes, even formulating medical insurance reimbursement guidelines prior to official product launch, with the goal of fostering globally leading BCI companies by the end of this decade. This policy environment has attracted significant capital inflows. Shanghai Jieti Medical Technology Co., Ltd. is one of the earliest domestic companies to start clinical trials of brain chips, with technical pathways similar to Neuralink. This week, the company completed a 500 million yuan RMB financing round led by Alibaba Group. Additionally, Chengdu Gota Technology Co., Ltd. announced the completion of a 150 million yuan RMB seed round. The company's R&D direction is similar to that of Merge Labs, led by Sam Altman. Risk Warning and Disclaimer The market involves risks; investments should be made cautiously. This article does not constitute personal investment advice and does not consider the unique investment objectives, financial situations, or needs of individual users. Users should consider whether any opinion, viewpoint, or conclusion in this article suits their specific circumstances. Investment decisions based on this are at your own risk. ```