In June 2026, Neuracle completed the world’s first commercial sale of an invasive BCI; three months earlier, Xiangya Hospital used the IMIE system to allow a blind person to “see” characters again. China’s BCI sector is taking the lead simultaneously on two battlefields: commercialization and clinical treatment. The progress of China’s invasive brain-computer interfaces is encouraging.
The World’s First BCI Medical Device Approved
On March 13, 2026, Neuracle’s semi-invasive BCI system obtained an NMPA Class III registration certificate, making it the world’s first commercialized invasive BCI product. Its clinical directions are epileptic focus localization and coma-state assessment. In 2024, the product had already entered the green channel for innovative medical devices. NMPA approval has moved faster, but the FDA has accumulated a longer history in BCI safety databases. Whether regulation should be aggressive or cautious has no standard answer.
China’s BCI Industry Landscape
China’s BCI sector is taking two paths: invasive systems are targeting serious medical care, while non-invasive systems are pursuing the consumer market.
On the invasive side, Neuracle is the only company in the world to have commercialized invasive BCI. In May 2026, Neuracle launched a clinical trial for a 128-channel fully implantable BCI. Xiangya Hospital’s IMIE system is pulling BCI applications from “diagnosis” toward “sensory reconstruction.” According to the “2026 China Brain-Computer Interface Industry TOP30,” the domestic substitution rate among leading companies in the upstream supply chain has exceeded 60%.
The largest non-invasive player is BrainCo. Its Revo series has already established sales channels in education and sleep. However, EEG signals attenuate f severely after passing through the skull, and the gap with invasive systems remains obvious.
| Technology Type | Representative Company / Institution | Main Applications | Stage |
| Invasive (semi-implantable) | Neuracle | Epilepsy localization, coma assessment | Approved |
| Invasive (fully implantable) | Neuracle | Motor reconstruction, visual restoration | In clinical trials |
| Invasive (visual reconstruction) | Xiangya Hospital IMIE | Treatment of blindness caused by RP | Clinical breakthrough |
| Non-invasive | BrainCo | Cognitive enhancement, sleep | Commercialized |
Visual Reconstruction Breakthrough: The IMIE System
On June 5, 2026, Professor Xu Huizhuo’s team at Xiangya Hospital of Central South University announced a clinical breakthrough in invasive visual reconstruction. The IMIE (Intelligent Retinal Implant System) intelligent retinal system is equipped with a 256-channel flexible electrode. Its working principle is: an external camera captures visual information → the processor converts it into electrical signals → the electrodes stimulate nerves at the fundus → visual perception is reconstructed. Subjects who had been blind for many years can already recognize optotype characters and complete directional walking. This is the first time globally that BCI visual reconstruction has advanced from “perceiving light” to “understanding characters.”
The 256-channel system is China’s first of its kind. Similar international products usually have only 60 channels. The more channels there are, the finer the stimulation contact points, and the higher the visual resolution.
| Product | R&D Institution | Number of Channels | Clinical Stage |
| IMIE | Xiangya Hospital | 256 channels | Clinical stage, with obvious effects |
| Argus II | Second Sight (United States) | 60 channels | Approved, discontinued |
| PRIMA | Pixium Vision (France / United States) | Approximately 40–60 channels | In clinical trials |
| CORTIVIS | Cortigent (United States) | Approximately 60 channels | Early clinical stage |
The targeted indication is retinitis pigmentosa (RP). China has approximately 300,000 patients, and the global figure exceeds 2 million. Apart from RPE65 gene mutations, which account for approximately 2–8% and for which gene therapy has already been approved, the vast majority of RP patients still have no effective treatment. The 256-channel platform technology may in the future be extended to other eye diseases such as macular degeneration and glaucoma.
IMIE is not taking the path of “reading brain signals → driving external devices,” but rather “encoding external information → inputting it into the brain.” Academia refers to this as “ascending BCI” or sensory-substitution BCI. The technical difficulty is greater, but the market space it opens is also completely different.
Capital Enters the Field
The commercialization signal brought by the approval quickly reached the capital market. After Neuracle’s 128-channel system entered clinical trials, a new round of financing began moving forward; in June 2026, news emerged that it was preparing for an IPO, with expected valuation exceeding RMB 4 billion, approximately USD 550 million. BrainCo has also started preparations for a listing in the United States or Hong Kong, with a target valuation exceeding RMB 12 billion, approximately USD 1.66 billion.
Before 2026, BCI financing relied on “technology concepts” and “future imagination.” After the March approval, investors saw a commercialization path that could genuinely be completed. IMIE’s visual reconstruction breakthrough further pushed up the valuation of the track—if BCI can allow blind people to regain sight, or even be used for hearing recovery, its market value will far exceed that of motor-control BCI. According to forecasts from the “2026 China Brain-Computer Interface Industry TOP30,” China’s BCI market size will exceed RMB 80 billion, approximately USD 11.0 billion, by 2030, with CAGR exceeding 35%.
Neuracle Route
Semi-invasive → clinical trials → commercialization
Advantage: fast approval, controllable risk
Neuralink Route
Aggressive fully implantable route
Advantage: high technological ceiling
Xiangya IMIE Route
256 channels → sensory reconstruction
Advantage: channel count leads the world
V. Divergence Between Chinese and U.S. Paths
As of June 2026, Neuralink’s PRIME and VOICE trials had enrolled a total of 21 people, according to Neuralink’s January 2026 announcement, mainly for paralyzed patients to operate devices and for ALS patients to speak. Neuralink has not yet obtained commercial approval in any country.
The reasons for Neuracle’s lead are: semi-invasive systems are easier to get approved; the NMPA green channel accelerates the process; and a domestic substitution rate of more than 60% in the upstream supply chain provides a foundation for commercialization. IMIE, meanwhile, has proven that China is equally competitive in original technology: its 256-channel electrode is one international generation ahead in channel density.
Neuralink itself has no shortage of trouble. The FDA only approved its first human trial in May 2023, after having rejected it multiple times earlier on safety grounds. In December 2024, Reuters reported that the FDA found its animal laboratory to be “non-compliant,” and the SEC also reopened an investigation. The Guardian reported in 2022 that more than 1,500 animals had died in experiments. Public opinion pressure has slowed the pace of approval.
Synchron is another variable. Its endovascular interventional BCI does not require craniotomy. In June 2026, it announced the launch of a pivotal trial and had completed early validation in 14 patients, according to a June 7 report by Tech Times. The FDA is also studying ways to simplify the BCI approval pathway. If implemented, multiple BCI products could potentially be approved within the next 12–18 months.
Competition in the BCI industry will eventually move from “who gets approved first” to ecological considerations: physician training, rehabilitation networks, insurance coverage, data regulations, and public acceptance. Beijing, Shanghai, and Shenzhen have already introduced dedicated BCI policies. However, China still has gaps in basic research, original algorithms, and the formulation of international standards. The emergence of IMIE has given China its first clinical report card in the more difficult track of “ascending sensory reconstruction.”
Over the past six months, good news in China’s invasive brain-computer interface sector has come one after another: a Chinese company was the first to obtain a commercialization entry ticket; Xiangya IMIE allowed blind people to see light again, opening a new world for brain-computer interfaces. Across the ocean: Synchron is catching up, the FDA is changing, and Neuralink is still entangled with ethics. The competition between China and the United States in brain-computer interfaces has only just begun. The real show is still ahead.
[Disclaimer]: The above content reflects analysis of publicly available information, expert insights, and BCC research. It does not constitute investment advice. BCC is not responsible for any losses resulting from reliance on the views expressed herein. Investors should exercise caution.