Monday, October 19, 2026
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Tag: NMPA

8 articles

Industry News

NeuroXess participant uses his brain implant to steer AI from sketch to 3D-printed figurine

NeuroXess (脑虎科技), the Shanghai brain-computer interface developer, disclosed on 30 September 2026 that a man with a C4 spinal cord injury, implanted in April 2026 with its fully implanted, fully wireless Triple-Full system, used it to draw a sketch and enter prompts, from which a large AI model generated design options and one was 3D-printed as a figurine. Using AI smart glasses and NeuroXess's XessOS software, he also adjusted his hospital bed and switched lights and household devices by confirming his intent. NeuroXess describes the work as clinical exploration and released no speed or accuracy figures. The Triple-Full system is in a registration trial led at Huashan Hospital that began on 7 July 2026, with an estimated 32 participants and primary completion estimated for 30 January 2027, and entered the National Medical Products Administration's innovative device review in July.

Oct 2

Policy & Regulation

Chinese Academy of Sciences names brain-computer interfaces a priority field in its 2026 to 2030 plan

The Chinese Academy of Sciences (CAS), China's top state research body, announced on 28 September 2026 that it had released its 15th Five-Year development plan covering 2026 to 2030. The plan lists brain-computer interfaces among its 'important priority fields' (重要优先领域), alongside integrated circuits, artificial intelligence, quantum science and technology, life sciences and biotechnology, and controlled nuclear fusion. CAS will organise research around a '3+4+X' regional layout with Shanghai as one of three strategic highlands, and will explore forming field-based research consortia, mission-based task forces and platform-based facility clusters across its institutes. CAS already runs its own invasive BCI programme: a system developed at its Shanghai Center for Excellence in Brain Science and Intelligence Technology (CEBSIT) was implanted in its first trial participant at Huashan Hospital in March 2025, and StairMed, founded by CEBSIT researcher Zhao Zhengtuo, entered the National Medical Products Administration's innovative device green channel in November 2025 with a market target of around 2028. CAS was one of the seven co-signatories of the 2025 BCI industry implementation opinions. The plan lands six days after Premier Li Qiang inspected BCI products in Shanghai and called future industries a blue ocean for advanced manufacturing. No BCI budget, programme names or milestones have been made public.

Sep 30

Policy & Regulation

China issues a medical-device standard for AI processing of EEG data in brain-computer interfaces

China's National Medical Products Administration (NMPA) has issued what state news agency Xinhua characterises as the world's first medical-device standard covering AI-processed electroencephalogram (EEG) data in brain-computer interfaces, announced on 14 September 2026. The standard was drafted by the National Institutes for Food and Drug Control (NIFDC) under an expedited procedure and becomes effective on 1 September 2027. Scope: quality requirements and evaluation methods for EEG datasets used by AI algorithms in BCI medical devices, covering collection, processing, annotation, storage, and access across R&D, production, and quality-control stages. Named NMPA and NIFDC officials: Yuan Peng (Deputy Director, NMPA Department of Medical Device Registration), Li Shu (Deputy Director, NIFDC medical device institute), Zheng Jia (Deputy Director, NIFDC Institute for Medical Device Standardization). This is the third BCI-related medical-device standard issued by China in twelve months, following 2025 standards on BCI terminology and on test methods for implantable closed-loop neural stimulators. The US FDA has no BCI-specific AI/EEG data-quality standard. The EU has no BCI-specific standard, only horizontal AI Act coverage of medical BCI as high-risk. On the narrow AI-EEG-BCI slice, China's world-first framing holds up.

Sep 17

Market Moves

Tianjin regulator clears Tiankai Suishi's non-invasive EEG cap for cognitive-impairment diagnosis

The Tianjin Municipal Medical Products Administration approved a non-invasive EEG-cap diagnostic device made by Tianjin-based Tiankai Suishi Intelligent Technology on 19 August 2026 for assessing cognitive impairment. The device sits in the diagnostic tier of China's growing brain-computer interface pipeline: Class II non-invasive rather than the Class III invasive category cleared by Neuracle in March 2026. Tiankai Suishi is a Tianjin University-linked startup founded 2023, led by Gu Bin, with a depression-diagnosis product also filed with NMPA. The approval extends China's Industrial Builder posture from a single invasive-BCI flagship into diagnostic-device territory anchored on the country's ageing-population indications: Alzheimer's, schizophrenia-linked cognitive dysfunction, and depression.

Sep 3

Industry News

Chinese BCI programmes produced four tangible results in July

In one month, four separate Chinese brain-computer interface programmes each produced a public result. Neuracle wrote the world's first commercial prescription for an invasive BCI at Huashan Hospital on 13 July. NeuroXess ran a two-patient cross-city Chinese chess demonstration between Shanghai and Nanchang. StairMed's investigational trial put three quadriplegic patients into paid remote work. And at the World AI Conference in Shanghai, a paralysed fine-arts graduate from Shenzhen demoed a mind-controlled wheelchair he had built himself with LLM-assisted DIY.

Jul 31

Industry News

China performs first commercial Neuracle NEO implant

On Monday 13 July 2026, neurosurgeons at Huashan Hospital affiliated with Fudan University performed the first commercial implantation of Neuracle's NEO brain-computer interface in a male patient with tetraplegia from a decade-old cervical spinal cord injury. The device is coin-sized, epidural, battery-free, and drives a pneumatic glove for hand grasping. Neuracle NEO is the world's first commercial invasive brain-computer interface implant for motor restoration in paralysis, following NMPA Class III market approval on 13 March 2026.

Jul 16

Policy & Regulation

China's NMPA locks BCI device classification: every implant is Class III, one narrow Class II lane

China's National Medical Products Administration issued Announcement No. 24 (2026) on 29 June 2026, releasing final Guiding Principles for the Classification and Definition of Brain-Computer Interface Medical Device Products plus a companion Generic Naming Guidelines. Every invasive BCI is Class III. Non-invasive BCIs are Class III by default. Non-invasive stroke-motor rehabilitation devices are Class II only if they do not incorporate artificial intelligence.

Jul 4