China’s Brain-Computer Interface Push Reaches Clinic

China’s brain-computer interface (BCI) industry is accelerating from laboratory research toward real-world medical use, propelled by landmark regulatory approvals, a surge in venture financing and the formation of the country’s first dedicated industry cluster in Shanghai, according to Xinhua News.

In March 2026, Shanghai-based Boruikang Medical Technology received the world’s first Class III medical device registration certificate for an invasive BCI — the NEO-ONE SCI system — marking the first complete closed loop from laboratory to clinical application for such a device globally, the report said.

From Lab to Operating Table

Within four months of approval, Huashan Hospital of Fudan University issued the world’s first clinical prescription for an invasive BCI, helping a patient paralyzed for years regain hand control. The patient had suffered a spinal cord injury in a car accident a decade earlier that impaired his grasp; the system collects and decodes epidural EEG signals to identify motor intent, building a pathway between brain and device, Xinhua reported.

“Besides the one product already approved, Shanghai currently has five Class III products in clinical trials and review and approval stages,” said Wang Zhuoyao, a BCI project manager at the Shanghai Science and Technology Commission. Three invasive BCI products from Shanghai have entered the national Innovative Medical Device Special Review Program, and one has received FDA Breakthrough Therapy Designation.

Beyond the invasive route, non-invasive technologies are advancing in parallel. Shanghai Kōngshāncí Technology presented what it describes as the world’s first integrated transcranial magnetic neuromodulation navigation system for depression, combining functional MRI, structured-light 3D cameras, electromagnetic field simulation and robotic-arm automation. Its product director, Zeng Huaiyang, framed the shift succinctly: “Traditional treatment is ‘one target for a thousand people’; we do ‘one target per person.’” Clinical data showed that after one week of treatment, 80 percent of 10 depression patients saw their Hamilton scale scores drop by more than 50 percent.

Building the Data Foundation

Moving BCI from the lab to the clinic depends on data. Intracranial EEG can only be collected during neurosurgery, and cross-center sharing has long been hampered by privacy, ethics and format barriers — creating “data islands.” Lingxiyun Medical Technology, which began accumulating brain-function data in 2019, now holds a petabyte-scale clinical and research database covering roughly 2.1 million cases spanning EEG, imaging, scales, medication and follow-up.

Huashan Hospital leads the iBRAIN EEG data alliance, which brings together 16 hospitals and about 1,000 high-quality intracranial EEG cases. The alliance uses a “usable but not copyable” sharing model, allowing data to flow safely across institutions without breaching patient privacy. “No matter which hardware it’s for, scientists can understand what happened just by seeing the data,” said Wu Zehan, a neurosurgeon at the hospital.

Three Hurdles to Commercialization

The path from research to market still requires clearing what industry participants call “three hurdles”: proof of concept, clinical trials and registration approval. The Sinan BCI super-incubator’s proof-of-concept platform reviewed more than 50 early-stage projects, with 14 passing validation and entering incubation, drawing over 1 billion yuan in cumulative financing, according to the Xinhua report.

The Shanghai Medical Device Testing Institute handles more than 90 percent of the country’s implantable BCI type testing and has led China’s first BCI medical device industry standard, with six national standards under development.

Policy support has been central to the momentum. China’s 15th Five-Year Plan explicitly names BCI as a new economic growth point, and the 2026 Government Work Report included it for the first time. In July 2025, seven ministries including the Ministry of Industry and Information Technology issued implementation guidelines targeting breakthroughs by 2027. In December 2025, the national drug regulator added implantable BCI devices to its priority approval catalog, and the national health insurance authority has since established independent charging codes, with Hubei province publishing the country’s first BCI medical service price in March 2026.

A Financing Surge and a Long Road Ahead

Capital has followed. According to 21st Century Business Herald, China’s BCI financing reached about 3.8 billion yuan in the first quarter of 2026 alone, surpassing the roughly 1.45 billion yuan for all of 2025. BrainCo completed a 2 billion yuan pre-IPO round at a post-money valuation above US$1.3 billion — the second-largest single BCI financing globally after Neuralink — and is reportedly preparing a Hong Kong listing.

Shanghai’s cluster, called Brain-Smart World (脑智天地) in Minhang District, has registered more than 50 BCI innovation companies since unveiling in 2025. As of June 2026, Shanghai had recorded 16 BCI financing events — 59.26 percent of the national total — worth about 2.117 billion yuan.

Yet commercialization remains in its early stages. Boruikang’s 2025 revenue exceeded 100 million yuan, almost entirely from non-invasive products like EEG machines, while its invasive product remains in development. The company recorded cumulative losses of about 328 million yuan from 2023 to 2025 and expects profitability only around 2029 to 2030, according to the 21st Century Business Herald.

“Getting the certificate is only the starting point,” said Cui Junzhe, chief operating officer of Sunao Technology. “Whether doctors are willing to use it, whether patients can afford it, and how the rehabilitation system and after-sales service are built — there are still many problems ahead.”

Industry observers also caution against overstating the field’s reach. “BCI is not omnipotent; it can only demonstrate its value in specific scenarios,” said Ni Guangjian of Tianjin University and the Haihe Laboratory, urging the industry to “objectively identify the application scenarios it truly fits.” Pu Yunhai, CEO of Chengdu-based Naojia Technology, argued that the real barrier to scale is not technology but three constraints: quantifiable evidence of clinical efficacy, affordable total cost, and the comfort needed for long-term compliance.

What’s Next

The coming years will test whether China’s early regulatory and clinical lead translates into durable commercial advantage. With Beijing’s Haidian District and other regions releasing their own BCI industry plans, competition among clusters is intensifying. As Wang of the Shanghai Science and Technology Commission put it, “Ultimately how many projects and products can truly ‘break out’ is what we need to keep watching.”