First-Ever Invasive Brain-Computer Interface Approved Globally: 2026 Marks the Dawn of Mass Production

Open Source Securities released a research report stating that Neuracle's "NEO System" has been approved by the National Medical Products Administration, becoming the world's first invasive brain-computer interface medical device to enter clinical use. The system assists hand grasping by reading brain signals, with some patients showing signs of neural remodeling, potentially upgrading from functional compensation to neural rehabilitation. With policy support, companies such as StairMed and NeuroXess are accelerating progress, with 2026 set to become the first year of mass production for implantable brain-computer interfaces, and China-based production lines soon to be operational.

The main viewpoints of Open Source Securities are as follows:

World's First Invasive Brain-Computer Interface Approved, Neuracle's IPO Process Expected to Accelerate

Neuracle's Implantable Brain-Computer Interface Hand Movement Compensation System (NEO) Approved by China's National Medical Products Administration, Marking the Clinical Application Stage of the World’s First Invasive Brain-Computer Interface Medical Device. The system consists of hardware and software components including an implantable brain-computer interface device, an implantable EEG electrode kit, an EEG signal transceiver, a pneumatic glove device, and EEG decoding software. By implanting electrodes epidurally to read EEG signals, the system assists in compensating for hand grasping functions through the pneumatic glove device. Three months post-surgery, participants achieved a 100% response rate in grasping tasks with the aid of the brain-computer interface, showing significant improvement in average ARAT scores, validating the safety and clinical feasibility of the semi-invasive technology pathway. Following NEO's approval, efforts will be accelerated to accumulate more real-world samples and long-term follow-up data to verify its stability and explore diversified commercial payment models, which is expected to expedite Neuracle's path to public listing.

Functional Compensation Evolves Towards Neurorehabilitation, with Scope and Capability Boundaries Gradually Expanding

The first patient in the NEO system, after removing the exoskeleton brace, not only showed improved grip ability but also regained the ability to write independently, indicating signs of neural remodeling in some patients with additional recovery of partial neurological functions. Therefore, the industry believes that Neuracle's device recognition is expected to upgrade from functional compensation to neurorehabilitation.

Neuracle's newly approved product is NEO 1.0, which, for clinical registration purposes, is currently only applicable to patients with quadriplegia caused by cervical spinal cord injury. The under-development 2.0 version aims for higher throughput, greater bandwidth, and broader indications, incorporating fine motor functions, language decoding, and achieving independent control of core components. As its capabilities continue to expand, the addressable market is vast and continuously growing.

Policy Tailwind Boosts Industry Takeoff, Expedited Pre-approval Accelerates Product Launch

As a future industry identified in the "15th Five-Year Plan" outline, brain-computer interfaces (BCIs) have received resource prioritization from the National Medical Products Administration (NMPA) in product evaluation and approval processes. Following the principles of "early intervention, tailored strategies for each enterprise, full-process guidance, and research-evaluation collaboration," the NMPA has implemented pre-assessment services for innovative products, effectively expediting their market entry and significantly enhancing the international competitiveness of China’s high-end medical devices. The "Action Plan for the Future Industry Development of Brain-Computer Interfaces (2025–2030)" issued by Shanghai explicitly aims to advance over five invasive and semi-invasive products through clinical trials by 2027. With Neuracle taking the lead as the first to break through to market, the sector believes that companies such as StairMed, Xinwei Medical, and NeuroXess are also expected to accelerate type inspection and clinical trial progress, strengthening the synergistic effects within the brain-computer interface industrial cluster.

2026: The First Year of Mass Production for Implantable Brain-Computer Interfaces, with Domestic Production Lines Likely to Launch Soon

StairMed's ultra-flexible neural electrode MEMS production line plans to increase the annual output of implantable ultra-flexible neural electrodes by 30,000 units. The industry believes it is expected to be completed by 2026, laying the foundation for subsequent mass production and market promotion. Considering that StairMed's "Implantable Wireless Brain-Computer Interface System" has entered the special review process for innovative medical devices ("green channel"), the acceleration of commercialization is highly anticipated. NeuroXess's "Super Factory" officially broke ground in January 2026 in Ganjiang New Area, undertaking the mass production task of China’s first "fully implanted, fully wireless, fully functional" brain-computer interface system. Neuralink also announced plans in 2026 to initiate large-scale production of brain-computer interface devices. Both domestic and international implantable brain-computer interfaces are entering the first year of mass production. The industry recommends: paying close attention to the completion milestones of domestic implantable brain-computer interface production lines.

Benefiting Targets:Heart玮 Medical, 翔宇 Medical, 美好 Medical, 迈普 Medicine, 三博 Brain Science, 乐普 Medical, 爱朋 Medical, 创新 Medical, 博拓 Biological, 诚益通, 岩山 Technology, etc.

Risk Warning:Commercialization promotion falls short of expectations; risks of technological iteration; risks of long-term safety and stability.