World's First Invasive Brain-Computer Interface Cleared for Market, Marking Entry into Commercial Validation Phase

Research Report Summary

Recently, the National Medical Products Administration approved the innovative product registration application of Neuracle's implantable brain-computer interface hand motor function compensation system, marking the world's first launch of a brain-computer interface. This is a milestone event for China’s invasive brain-computer interface industry, transitioning from "technical validation" to "commercial implementation," and relevant investment opportunities in related companies are worth attention.

The First Invasive Brain-Computer Interface Product Approved for Market Release, Establishing a New Era of Commercialization. Neuracle's product consists of a brain-computer interface implant, an implantable electroencephalogram (EEG) electrode kit, an EEG signal transceiver, a pneumatic hand device, a disposable surgical toolkit, EEG decoding software, medical testing software, and clinical management software. It is suitable for patients with quadriplegia caused by cervical spinal cord injury, assisting in the compensation of hand grasping function through the pneumatic hand device. The product utilizes minimally invasive epidural implantation and wireless power supply communication technology. Clinical trial results show that subjects significantly improved their hand grasping ability using this product, thereby enhancing their quality of life. The approval of Neuracle's implantable brain-computer interface product marks the official entry of the world’s first invasive brain-computer interface medical device into clinical application, representing a milestone event where China’s brain-computer interface industry transitions from "technical validation" to "commercial implementation."

Policy Combo Continues to Boost, Brain-Computer Interface Industry Enters Development Bonanza. Recently, in the "15th Five-Year Plan" Outline (Draft), brain-computer interface has been explicitly listed as one of the key future industries fostered by China, establishing its strategic development position. Since 2025, seven departments including the Ministry of Industry and Information Technology have issued the "Implementation Opinions on Promoting Innovation and Development of the Brain-Computer Interface Industry"; the National Medical Products Administration approved and released China's first brain-computer interface medical device standard; the National Healthcare Security Administration established new price items related to brain-computer interfaces, clarifying charging criteria, with relevant policies for brain-computer interfaces being successively implemented. On December 24, 2025, the National Medical Products Administration included "Implantable Brain-Computer Interface Medical Devices" in the "Priority Approval Directory for High-End Medical Devices", and the approval of Neuracle's brain-computer interface products also...Innovative HealthcareThe Practical Implementation of the Expedited Review Policy for Devices. From setting the tone for top-level industrial development, accelerating approvals, to the implementation of hospital-end billing projects, the effects of the policy package are gradually becoming evident, speeding up the commercialization process of the brain-computer industry.

The brain-computer interface market has broad prospects and significant growth potential. According to Fortune Business Insights, the global brain-computer interface market size is expected to reach approximately $240 million by 2025 and grow to $960 million by 2034, with a compound annual growth rate (CAGR) of about 15.9% from 2026 to 2034. In the Chinese market, data from the China Industrial Research Institute shows that the market size of brain-computer interfaces in China will be 3.2 billion yuan in 2024, increasing by 18.81% year-on-year, and is expected to reach 4.6 billion yuan by 2026. From the current progress of the industry, non-invasive technology, with its high safety and low cost advantages, has been first applied in rehabilitation and consumer scenarios. Meanwhile, invasive technology is gradually achieving clinical progress in high-value medical applications. With the upcoming launch of core products, the brain-computer interface industry is transitioning from technological exploration to a key phase of scaled commercial application, indicating substantial future growth potential.

Investment Advice

We believe that, with the approval and market launch of the world's first invasive product, China's brain-computer interface industry has entered the commercial validation phase. It is recommended to focus on brain-computer interface related enterprises.

Main risks facing the rating:Risk of Commercial Promotion Below Expectations: In the early stage of new product launch, the product uptake may be slower than expected due to factors such as doctor training, hospital access, and patient affordability. Long-term Safety and Stability Risks: After the product is launched, its long-term safety and stability still need to be verified in large-scale applications.