Domestic Invasive Brain-Computer Interface Enters Regulatory Fast Track as Capital Floods Into Frontier Medical Blue Ocean

Source: Securities Daily Network

Reporter Zhang Xiaoyu of this newspaper

Recently, the "Implantable Wireless Brain-Computer Interface System" independently developed by Shanghai StairMed Technology Co., Ltd. has officially entered the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration.Innovative HealthcareSpecial Review Procedure for Devices (also known as the "Green Channel"). This marks a key step in the industrialization process of invasive brain-computer interface products in China, moving from clinical validation to market access, drawing widespread attention from both the capital market and the technology community.

Core Breakthrough: Invasive Products Open the Industrialization Gateway

Brain-computer Interface (BCI), as a revolutionary technology connecting the brain with external devices, is regarded as the core direction of the next generation of human-computer interaction. Currently, there are two mainstream technical routes for brain-computer interfaces: invasive and non-invasive. Invasive products, due to their characteristic of being directly implanted in the cerebral cortex and providing more precise signal transmission, have become the most valuable technical path in medical applications.

"Shanghai StairMed's 'Implantable Wireless Brain-Computer Interface System' entering the 'green channel' is a vivid example of China's high-end medical devices transitioning from scale development to quality improvement, and it aligns closely with the reform direction of the National Medical Products Administration's 'regulatory promotion of innovation,'" Xu Jiarui, Director of the Data Center at the Guangdong Institute of New Biomaterials and High-End Medical Devices, told reporters from the Securities Daily.

"Policies Create a Supportive Environment for the Brain-Computer Interface Industry." Hu Qimu, a specially invited researcher of the China Enterprise Confederation, stated in an interview with *Securities Daily*, "The implementation of the 'green channel' significantly reduces the cycle from product development to market launch. Previously, the review period for such products could take 3-5 years, but with the green channel, it is expected to be shortened to 1-2 years, which is crucial for rapidly evolving frontier fields."

This breakthrough is backed by the continuous improvement of China's brain-computer interface industry chain. Data shows that a complete industrial chain has been formed in China, covering multiple links including upstream materials, chips, and electrodes, midstream signal acquisition and processing, and downstream healthcare, medical treatment, and consumer applications. In the upstream sector, domestically produced medical-grade flexible electrode materials have been successfully localized; in the midstream sector, signal processing algorithms are continuously optimized with the support of artificial intelligence technology; in the downstream market, healthcare and medical treatment have become the core scenarios for early implementation, providing a clear commercialization path for technological industrialization.

Hu Qimu stated: "Progress in the upstream of the industrial chain, such as more biocompatible materials, higher-throughput microelectrodes, and lower-power chips, forms the foundation for performance improvement in mid- and downstream products. The signal processing and decoding algorithms in the midstream act as the 'brain' of the technology, with their level of intelligence directly determining the practical effectiveness of the system. In downstream applications, the medical field, due to its clear clinical needs and paying parties, has a relatively straightforward commercialization path."

Capital Influx: Accelerating Technology Transformation and Industry Integration

According to McKinsey's estimates, the global brain-computer interface market size in medical applications is expected to reach 40 billion US dollars by 2030, and exceed 145 billion US dollars by 2040.

In China, with the increasing policy support and frequent technological breakthroughs, the market size is expanding at a faster rate. According to a report by the China Business Industry Research Institute, the market size of brain-computer interface in China reached 3.203 billion yuan in 2024, increasing by 18.81% year-on-year. Analysts at the China Business Industry Research Institute predict that the market size of brain-computer interface in China will reach 3.830 billion yuan in 2025.

As an important direction of frontier technology, brain-computer interface has been included in the national strategic planning of multiple countries, with continuous increase in policy support. The capital market also pays high attention to the brain-computer interface track. According toTianfeng Securities"Brain-Computer Interface Investment Map" data shows that the annualized growth rate of financing events in China's brain-computer interface industry exceeded 30% from 2018 to 2024, with 20 new financings added in just the third quarter of 2025, 70% of which were pre-Series B projects.

"The influx of capital will accelerate technology transfer and industry integration." Hu Qimu stated that brain-computer interface, as a long-cycle and high-investment track, requires continuous support from the capital market. The industry is still in its early stages of development, with technical routes and business models still being explored. In the future, with the rise of leading enterprises, industry concentration will gradually increase, forming a healthy development pattern. Meanwhile, as the technology matures, application areas will expand into fields such as consumer lifestyle and industrial production.

Continuous breakthroughs in clinical applications have provided core momentum for market growth. FujianSanbo Brain HospitalThe interventional brain-computer interface trial completed by the hospital successfully achieved precise acquisition and decoding of neural signals, demonstrating the feasibility of domestically produced technology in clinical scenarios; the medical version product of Blooming BCI, a subsidiary of StairMed, has completed more than 100 multi-center clinical tests.

In Xu Jiarui's view, brain-computer interfaces and other emerging technology fields are currently at a critical stage of rapid development. However, there is still a lack of mature standard systems in areas such as long-term biocompatibility and signal stability evaluation, which is a core issue that urgently needs to be addressed in China. To this end, on the one hand, clinical, research and development, and regulatory experts should collaborate to develop targeted review tools, transforming practical data from companies like StairMed into quantifiable evaluation metrics. On the other hand, through an "early intervention and full-process guidance" model, support for clinical trial design and ethical review can be provided for these high-risk innovative products, aligning with the national reform requirement of "research and review linkage."

(Editor Cai Shandan)