Brain-Computer Interface Sector Heats Up Again: FDA Breakthrough Designation Draws Attention, Domestic Industrial Layout Accelerates

　　【Pharmaceutical Network | Industry Trends] During the May Day holiday, the brain-computer interface (BCI) sector heated up once again. On May 2 local time, Neuralink, Elon Musk’s BCI company, announced on social media that its BCI device, Link, had recently received “Breakthrough Device” designation from the U.S. Food and Drug Administration (FDA). This device will provide a revolutionary communication solution for patients with severe speech impairments.
 

It is reported that the device is primarily designed for patients with neurological disorders such as amyotrophic lateral sclerosis (ALS), stroke, and spinal cord injury. Newly released cases reveal that Bradford Smith, an ALS patient and the third participant in the PRIME study, successfully regained his ability to communicate after implantation of the Link device. He can not only control a computer cursor with his thoughts to type text but also express himself using an AI-synthesized personal voice, and has even independently edited a demonstration video.
 

Industry experts point out that brain-computer interfaces, as a representative field of new quality productive forces and one of the important directions for future industrial tracks, are accelerating the formation of breakthrough scientific achievements and innovative applications.
 

In China, new developments continue to emerge in the field of brain-computer interfaces: the flexible microelectrode implant developed by the Institute of Automation, Chinese Academy of SciencesRobotRecently passing preliminary acceptance, this technology provides critical support for brain-computer interface (BCI) research. On March 31, the Hubei Provincial Healthcare Security Administration released China’s first pricing standards for BCI medical services: CNY 6,552 per procedure for invasive BCI implantation, CNY 3,139 per procedure for invasive BCI explantation, and CNY 966 per session for non-invasive BCI adaptation. The “dual-loop” BCI system, jointly developed by Tianjin University and Tsinghua University, has broken through traditional control limitations, further consolidating China’s position in the field of non-invasive BCIs. Beijing and Shanghai have successively issued five-year action plans for brain-computer interfaces.
 

Industry analysts, when discussing investment opportunities in the brain-computer interface (BCI) supply chain, noted that the upstream segment involves the supply of hardware and software, such as BCI chips, databases, and related algorithms; the midstream segment focuses on the provision of BCI products, including brain signal acquisition platforms and BCI devices; while the downstream segment encompasses a wide range of applications. Going forward, investors are advised to focus on investment opportunities among companies across the BCI supply chain.
 

Since the beginning of this year, the technological layouts of related concept companies in the field of brain-computer interfaces (BCI) have also attracted attention. For instance, on April 25, Chengyitong stated on its interactive platform that BCI business is one of the key directions for the company’s future development. The company has been closely monitoring the development of related technologies and will carefully consider strategic investments in suitable projects in the future to further optimize its business portfolio and continuously enhance its core competitiveness.
 

Aipeng Medical stated on the interactive platform on March 13 that the company attaches great importance to the translation of brain-computer interface technology into product applications, as well as the establishment of a basic technical platform and professional team. The company has built a technology platform based on EEG acquisition, analysis, and product translation. At the same time, Shenzhen Pengrui Brain Science Technology Co., Ltd., which is controlled by the company, will rely on technologies such as brain-computer interfaces, flexible sensing, and intelligent algorithms in the future to engage in the research and development of digital diagnosis and treatment products and platforms for brain diseases in fields such as neurological disease diagnosis, cognitive training, and sleep monitoring. Currently, the revenue from this type of business accounts for a small proportion of the company's total revenue and has almost no impact on its operations.
 

In January, Edan Instruments also stated on its interactive platform that the company consistently monitors cutting-edge technologies, including brain-computer interfaces (BCIs), and fully recognizes their potential significant application value in the medical device sector. The company will closely track advancements in these technologies and industry dynamics, while conducting in-depth assessments of their commercial viability and market opportunities.
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice for any person.