Overview — China
China invasive BCI overview
This page maps where invasive brain-computer interface work in China stands, built from Chinese-language primary sources: the regulator (NMPA and its review center), the insurance administration (NHSA), the ministries’ own policy text, the Chinese Clinical Trial Registry (ChiCTR), the Shanghai Stock Exchange filing of the one company that has a cleared invasive product, and companies’ own news pages. English-language press is not used as evidence. Company statements are labeled as such. Where a number rests only on a repost or a press story, the row says so. Blank cells mean the source does not state the value. Last checked October 9, 2026.
Regulatory and policy timeline
| Date | Event | Source (type) |
|---|---|---|
| 2025-01 | NMPA issued a standard for medical devices using BCI technology: EEG dataset quality requirements and evaluation methods for AI algorithms. | NHSA explainer, Mar 12, 2025 (government, cites the NMPA standard; the standard text was not read) |
| 2025-03-11 | NHSA published the trial guide for nervous-system service price items. It created separate price items for invasive BCI implantation, invasive BCI removal and non-invasive BCI fitting. | NHSA (government) |
| 2025-07-23 | Seven bodies (MIIT, NDRC, Education, NHC, SASAC, CAS, NMPA) issued the opinion on BCI industry innovation, document 工信部联科〔2025〕164号. It sets targets for 2027 (key technology breakthroughs, electrodes, chips and complete devices at an internationally advanced level) and 2030 (two to three globally influential leading firms). | gov.cn (government) |
| 2026-03-13 | NMPA approved Neuracle’s (博睿康) implantable BCI hand motor function compensation system through the innovative-product route. The NMPA text calls it the first invasive BCI medical device to reach clinical use worldwide. Label: tetraplegia from cervical spinal cord injury, ages 18 to 60, C2 to C6, ASIA grade A to C, with a pneumatic glove for grasp. | NMPA text via Xinhua, Mar 16, 2026 (regulator text on a state outlet) |
| 2026-03-22 | NHSA reported the first insurance code for an innovative BCI product. | NHSA (government) |
| 2026-06-30 | NMPA announcement 2026 No. 24 issued the BCI product classification guidance and the BCI generic-name guidance. NeuroXess states that it makes invasive and implantable BCI products Class III. | NeuroXess news page (company statement); the notice text was read only on a third-party reprint |
| 2026-07-08 | NeuroXess started its GCP registration trial at Huashan Hospital. | NeuroXess news (company statement) |
| 2026-09-29 | Neuracle’s reply to the Shanghai Stock Exchange review states that since July 2026 it had completed 13 sales and 8 terminal implants of NEO-ONE SCI, with more than 70 orders in hand or intended. | SSE filing (company filing, page 8-1-136) |
The NMPA technical review report for the Neuracle product was published by the review center. The version read for sheet 41 is a repost on Tencent News, not the center’s own file, so figures taken from it are flagged there. The center’s own PDF for that report was not located. The center files that were located cover a different DBS product and are not used.
Invasive BCI trials in ChiCTR
Only records whose intervention is an implanted or endovascular BCI or related epidural stimulator are listed. The registry’s recruiting status field reads “not yet started” on every record below as fetched; it is often not updated, so it is not used as a status.
| Registration | Registered | Title (Chinese, translated) | Leader and site | Funding source | Design and size | Planned dates |
|---|---|---|---|---|---|---|
| ChiCTR2500102814 | 2025-05-20 | Safety and efficacy of an implantable wireless BCI in tetraplegia, multicenter | Mao Ying (Huashan); Zhao Guoguang (Xuanwu) | Neuracle (博睿康医疗科技(上海)有限公司) | Single arm, interventional, 32 subjects per the protocol text; ages 18 to 65 | 2025-05-20 to 2026-05-20 |
| ChiCTR2500095359 | 2025-01-06 | Brain-controlled closed-loop epidural stimulation for leg paralysis after spinal cord injury | Ding Jing (Zhongshan Hospital, Fudan) | Hospital development funds | Single arm, interventional, 3 subjects | 2025-01-01 to 2025-12-31 |
| ChiCTR2500095515 | 2025-01-08 | Short-term epidural stimulator for cervical spinal cord injury | Fan Jin (Jiangsu Province Hospital) | National Natural Science Foundation of China grant 82272499 | Cohort, observational; size not shown | 2025-01-15 to 2027-12-31 |
| ChiCTR2400093125 | 2024-11-28 | Endovascular BCI “type A sensor” for paralyzed limbs, safety | Lin Zhixiong (Fujian Sanbo Funeng Brain Hospital) | Tianjin Rongyuan Intelligent Technology (天津嵘元智能科技有限公司) | Non-randomized, 1 subject | 2024-11-01 to 2025-05-31 |
| ChiCTR2300070545 | not read | Artificial auditory brainstem implant system in NF2 patients | Wu Hao (Shanghai Ninth People’s Hospital) | Sponsor | Single arm, phase III; the registry’s English text names Zhejiang Norkang Neuroelectronic Technology Co., Ltd. as manufacturer | 2023-04-15 to 2026-12-31 |
The ChiCTR page for the NEO trial lists ages 18 to 65, while the NMPA label is 18 to 60; sheet 41 shows both.
Not found in ChiCTR in this pass: registrations for the StairMed, NeuroXess and Zhiran trials. Those companies state their trials in their own news. The NeuroXess GCP trial and the Zhiran GCP multicenter trial may be registered elsewhere or not yet public.
Company map
| Company | What it has, from its own pages or filings | Brief and sheets |
|---|---|---|
| Neuracle (博睿康), Shanghai | The only invasive BCI cleared by NMPA so far (Mar 2026). Filing states 13 sales and 8 implants since July 2026. The filing’s proposed use of proceeds totals 2.5 billion yuan (RMB 250,000万元, of which 1.54 billion yuan for BCI R&D) for an IPO of at most 20 million shares. These are planned figures, not funds raised. A consultancy forecast in the filing puts the ex-factory price near 200,000 yuan. | Neuracle brief, NEO sheet |
| NeuroXess (脑虎科技), Shanghai | Company says its fully implanted, fully wireless, fully functional (“three-all”) subdural system began a GCP registration trial on July 8, 2026 at Huashan, with 15 top-tier (三甲) hospitals in 12 provinces and regions. It plans a factory in Jiangxi (target: second half of 2026). Company claims. | NeuroXess brief, 256-channel ECoG, Triple-F system |
| StairMed (阶梯医疗), Shanghai | First human implant March 25, 2025 at Huashan per CAS. The 500 million yuan round led by Alibaba (reported March 2026) is from a trade-press story and was not matched to a company or filing source. The green-channel entry (reported November 2025) is likewise from press only. | StairMed brief, WRS, WRS02 |
| Zhiran (智冉医疗), Beijing | Its own news page lists a GCP multicenter trial of a more-than-100-channel system (May 19, 2026), a deep-electrode green-channel entry (May 21, 2026) and a 300 million yuan A+ round (headline, Feb 11, 2026). Company claims. A press story of a further round above 600 million yuan is an estimate from business-registration changes and is not used. | Zhiran brief, LEAP sheet |
| Shenfu Jianxing (神复健行), Shanghai | Brain-spine interface from Fudan; ChiCTR2500095359 above; reported by Fudan to be on the FDA Breakthrough pathway. | Shenfu brief, sheet |
| Mindtrix (明视脑机), Suzhou | Visual reconstruction system; founded October 2024 per press. | Mindtrix brief, sheet |
| Neucyber / Beinao-1 (北脑一号), Beijing | Implant counts differ across Chinese sources; the sheet lists all. A Beijing paper reported the seventh human implant in March 2026. | Neucyber brief, Beinao-1 sheet |
| Tianjin Rongyuan Intelligent Technology (天津嵘元智能) | Funds the endovascular “type A sensor” study in ChiCTR2400093125. The Nankai District government reports a first-in-human endovascular BCI trial (August 2025). | Rongyuan brief |
| Zhejiang Nurotron / Norkang (诺尔康) | Hangzhou, founded 2006 per its profile page. Makes cochlear implants and, with Shanghai Ninth People’s Hospital, a domestic auditory brainstem implant in ChiCTR2300070545. Company statements. | Nurotron brief |
Limits
- CNKI and other paywalled Chinese databases were not reachable and nothing was substituted for them.
- The NMPA announcements were read through Xinhua, a provincial NMPA mirror and reprints. The nmpa.gov.cn originals and the review center’s own report file for the Neuracle product were not opened.
- ChiCTR was searched with a limited set of queries, so the invasive-trial table is not a complete census.
- Financing amounts for StairMed and Zhiran, apart from the headlines on Zhiran’s own news page, rest on press and are not treated as confirmed.
- Next candidates: the NMPA original notices, the Zhiran and StairMed trial records, and the Beinao-1 registry records.