Recently, the "Implantable Wireless Brain-Computer Interface System" independently developed by Shanghai Step Medical Technology Co., Ltd. has officially entered the Innovative Medical Device Special Review Program of the Center for Medical Device Evaluation (CMDE) under China’s National Medical Products Administration (NMPA). This marks the first invasive brain-computer interface (BCI) product in China to enter this "green channel."

The Innovative Medical Device Special Review Program is a priority evaluation pathway established by the NMPA to encourage medical device innovation. It targets products with core patented technology, domestic originality, and outstanding clinical value, offering early intervention, dedicated support, and shortened review cycles—essentially serving as an accelerator for truly groundbreaking innovations.

To qualify, products must meet the following criteria: 1. **Innovation**: The applicant must hold core technology invention patents in China, either through independent R&D or legal transfer, with the patent authorization date no more than five years before the application. Alternatively, the core patent application must have been disclosed by China’s patent office, with a search report from the Patent Retrieval and Consultation Center confirming novelty and creativity. 2. **Feasibility**: The applicant must have completed preliminary research with a finalized product, ensuring controlled and traceable data. 3. **Clinical Value**: The product must be domestically pioneering in principle or mechanism, offering fundamental improvements in performance or safety over existing solutions, with international leadership and significant clinical applications.

Unlike non-invasive BCI products that rely on headgear to capture signals, invasive BCI requires surgical implantation of electrodes into the brain to interface with neurons. While this approach carries higher technical and safety risks, it delivers higher-quality, more precise neural signals. The inclusion of Step Medical’s product in the green channel reflects regulators’ growing confidence in the safety and efficacy of such technologies, paving the way for industrialization.

Founded in 2021, Step Medical focuses on implantable BCI technology, specializing in neural interfaces (electrodes) and platform development. It has yet to commercialize any medical devices in China. In February 2025, the company secured RMB 350 million in Series B funding led by Qiming Venture Partners, OrbiMed, and Lilly Asia Ventures.

Step Medical’s ultra-flexible electrodes, achieved through micro-nano fabrication and material innovation, are as thin as 1/100th of a human hair (cell-sized) while maintaining biocompatibility and mechanical strength. These electrodes are implanted into the brain and connected to a coin-sized cranial implant, wirelessly transmitting signals to external devices for translation into computer commands.

"Our implant is half the size of Neuralink’s," revealed Li Xue, Step Medical’s founder. Compared to Neuralink’s electrodes, the domestic version is not only smaller but also significantly softer, minimizing tissue damage and immune responses.

Step Medical’s circular implant measures 26mm in diameter and under 6mm in thickness, with electrode "tentacles" extending into the brain. On March 25, 2025, the company reported a milestone: a quadriplegic trial subject at Huashan Hospital, Fudan University, learned to control a computer cursor via BCI after three weeks of training, achieving performance comparable to touchpad use.

In May 2025, Step Medical launched China’s first pre-registration clinical trial for invasive BCI, becoming the world’s second such company after Neuralink to enter clinical stages.

Globally, BCI competition is intense. Invasive BCI trials are underway in both China and the U.S., while semi-invasive progress is faster in the U.S., and non-invasive solutions flourish in China. On October 11, Neuralink showcased ALS patient Nick Wray using BCI to eat via a robotic arm. Meanwhile, its first recipient, Noland Arbaugh, regained abilities like typing and gaming 21 months post-implant. Elon Musk hinted Arbaugh might receive upgrades or bilateral implants, potentially enabling superhuman gaming reflexes.

China has made strides in flexible, minimally invasive, and intelligent BCI research. Huaxi Securities highlights ultra-flexible electrodes and dynamic electrode paradigms as areas where China leads or matches global peers. Policy support is also accelerating: in September 2025, China’s healthcare authority streamlined BCI product coding for insurance reimbursement, while the NMPA issued its first BCI medical device terminology standard, effective January 2026.

Huaxi Securities notes dual drivers—policy and technology—position the sector for growth: 1. **Invasive BCI**: Focus on leaders like Step Medical, BrainCo, and Xinzhi Da, particularly in flexible electrodes and implantation tech. 2. **Semi-Invasive**: Track data-readout capabilities and trial scale (e.g., Borui Kang, Sanbo Brain, Xinwei Medical). 3. **Non-Invasive**: Prioritize firms blending medical and consumer applications (e.g., StrongBrain, Weisi Medical, Xiangyu Medical).

Market projections: - Global BCI market: $2.62B (2024), $2.94B (2025), $12.4B (2034; 17.35% CAGR). - China: RMB 3.2B (2024), RMB 6.14B (2028).

China’s 15th Five-Year Plan identifies BCI as a future growth engine, aiming to replicate high-tech industry expansion over the next decade.