BriTon Medical Secures Global First Approval for Invasive Brain-Computer Interface System, Files IPO Prospectus

(Source: China Food and Drug Administration Network)

China Food and Drug News (Reporter Luonan) A quadriplegic patient, by having an implant about the size of a coin placed on the skull and electrodes placed in the target brain area below the skull and above the dura mater, can use software to interpret movement intentions, achieving control of a paired glove device with thought, assisting the hand in completing actions such as grasping a water bottle to drink. This seemingly sci-fi scenario has now become a reality.

On March 13, the National Medical Products Administration approved the registration application of Neuracle Technology (Shanghai) Co., Ltd. for its implantable brain-computer interface system for hand motor function compensation. The product consists of an implantable brain-computer interface, an implantable electroencephalogram (EEG) electrode kit, an EEG signal transceiver, a pneumatic glove device, and EEG decoding software. It is suitable for patients with quadriplegia caused by cervical spinal cord injury, assisting in achieving hand grip function compensation through the pneumatic glove device. This also marks the first invasive brain-computer interface medical device in the world entering the clinical application stage, opening up a new space for commercial implementation.

Towards the Brain

In early March, Jin Jing, the registration director of Neuracle Technology (Shanghai) Co., Ltd. (hereinafter referred to as Neuracle), was filled with anticipation every day. At the beginning of March, Neuracle completed the verification of the registration information for its developed brain-computer interface product, and the approval of the product is imminent.

"It took more than a decade for the product to progress from laboratory technology to clinical application," Jin Jing told the reporter. The R&D of Neuracle is based on the company's own technical accumulation and the actual needs of clinical practice.

Neuracle was founded in 2011, with its core team originating from the Neural Engineering Laboratory of the School of Biomedical Engineering at Tsinghua University, focusing on brain-computer interface technology as a key research direction. The company early on recognized a large number of "silent patients" in the field of spinal cord injury: many patients have intact brain function areas, but due to damage to the central nervous system, the commands issued by the brain cannot be effectively transmitted to the limbs, resulting in quadriplegia. Many of these patients are under 50 years old.

Can the patient's motor intention be interpreted to achieve functional compensation? In this regard, Neuracle is advancing the transformation of brain-computer interface technology.

Brain-computer interface products come in different forms, such as non-invasive and invasive. Invasive products require implanting certain components into the brain. The choice of form directly affects the quality of EEG signal collection, but the level of risk for patients also varies significantly.

"We wanted to find a solution that neither damages brain cells nor obtains high-quality EEG signals, and ultimately chose to implant the electrodes under the skull and above the dura mater." Jin Jing explained that the quality of EEG signals collected in this way is dozens of times higher than that on the scalp, and it can avoid possible brain tissue damage caused by further deep insertion of the electrodes into the brain.

In 2019, Neuracle officially launched the research and development project, accelerating the transformation of the concept into reality. The company completed the production of laboratory prototypes and design development verification in 2021, conducted animal experiments and product type inspections from 2022 to 2023, and by October 2023 had progressed to the first human trial.

From Jin Jing's perspective, this acceleration is inseparable from the policy tailwinds in the brain-computer interface field in recent years, but the foundation lies in the technical reserves of enterprises.

"For us, the accumulation of relevant technology has continuity, and the path from laboratory research to enterprise product transformation is relatively smooth," explained Jin Jing. The R&D personnel of Neuracle's brain-computer interface not only understand brain-computer interface technology but also have accumulated experience in EEG signal acquisition and medical device transformation through the development of EEG machines in previous years.

However, the leap from new technology to new products is not easy. In the absence of mature experience to follow, Neuracle must achieve high-quality collection of EEG signals, accurately "translate" them through algorithms, and further drive supporting devices, requiring solutions to various key issues, such as ensuring the accurate "translation" of EEG signals.

Jin Jing told the reporter that modern medicine has conducted in-depth research on human movement and its EEG signal characteristics. Different hand movements result in distinct low-frequency and high-frequency characteristics of EEG signals in the brain's motor cortex. Based on this, Neuracle has developed an EEG algorithm that analyzes patients' movement intentions from collected EEG signals and continuously verifies the algorithm's accuracy through subdural EEG datasets, feasibility clinical research data, and clinical trial data.

To obtain hard-core evidence of product safety and efficacy, the key lies in large-scale clinical trials. Since May 2025, Neuracle has conducted multi-center clinical trials across 11 hospitals in China, enrolling a total of 32 subjects. The clinical trial results have strengthened the company's confidence.

Not Alone

"We can clearly feel that the drug regulatory authorities and enterprises are like a big team, working together to bring China's brain-computer interface technology from laboratory to clinical application." Jin Jing recalled the product development and registration process of Neuracle, with deep emotion.

"Early intervention, tailored strategies for each enterprise, full-process guidance, and research-review coordination" — the special support from the National Medical Products Administration (NMPA) for key products is fully embodied in this brain-computer interface product. From pre-guidance, evaluation, testing to inspection, all relevant departments at every stage have assisted enterprises without lowering standards.

Li Yaohua, Director of the Yangtze River Delta Branch of the National Medical Products Administration's Center for Medical Device Evaluation and Inspection (hereinafter referred to as the Branch), told reporters that more than two years ago, as an evaluation agency "at the doorstep" of enterprises, the Branch established contact with Neuracle. In August 2024, Neuracle's product enteredInnovative HealthcareAfter the special review procedure for devices, the Medical Device Technology Evaluation Center of the National Medical Products Administration specially established a 7-member evaluation working group to guide the company's product development and registration application work, with reviewers from the branch center also participating.

"This is an entirely new product. Not only does the design of the clinical trial protocol require joint discussions between the R&D company and the evaluators, but many technical issues also need to be studied together," introduced the evaluator from the sub-center. The product is a complex system that integrates numerous technologies, with many technical points to consider. During the evaluation process, the evaluators simultaneously assess and list problem items, which are then verified by the company.

Registration testing is an important part of the pre-market evaluation for medical devices. The Shanghai Medical Device Inspection and Research Institute continuously provides technical guidance and testing services for this product.

"The complexity of testing for this product has significantly increased compared to traditional medical devices," explained Hu Sheng, the deputy director of the hospital's Active Device Inspection Department. The product controls a配套的气动手套设备 through an implant, and the process involves algorithm technology. Its testing not only requires conducting different tests based on the risk levels of each component but also paying attention to the coordination between different components.

In response, the hospital strengthened its preliminary research, combining the characteristics of the product and past testing experience to analyze potential issues that may arise during the registration study. Additionally, the hospital maintained close communication with the evaluation department, clarifying their concerns and developing multiple contingency plans for possible testing key points.

"We have conducted necessary experiments on several contingency plans and prepared verification results, so that enterprises and review departments can communicate and finalize appropriate solutions based on risk control needs," said Hu Sheng.

Neuracle had no prior experience in producing Class III medical devices. In response, the Shanghai Medical Device and Cosmetics Review and Inspection Center (hereinafter referred to as the Shanghai Device Review Center) took proactive steps to fully assist the company in improving its quality management system. Since August 2024, the Shanghai Device Review Center has assigned senior inspectors, established a working group, coordinated collaboration across all departments, and continuously responded to the company's service needs.

Yang Yiqiang, head of the Department of Verification of Powered Medical Devices at the Shanghai Instrument Review Center, introduced that in terms of establishing quality management systems, there are differences in the detailed professional requirements for different medical devices. Carrying out early intervention guidance can help companies understand the regulatory requirements for high-risk medical devices and also help inspectors gain a deeper understanding of innovative technology features, further enhancing their knowledge of key product quality control points.

At the request of the company, the Shanghai Instrument Review Center organized two rounds of early inspection services and "face-to-face" on-site guidance. Among these, a comprehensive pre-inspection was carried out in January 2026, where four senior inspectors spent four days examining the main processes of the company’s R&D, production, and testing, as well as the quality control key points of the product's core components to identify weaknesses. This effort laid a solid foundation for the company to successfully pass the registration inspection in the future.

At around 9 a.m. on February 12, after receiving the verification task from the Center for Medical Device Evaluation of the National Medical Products Administration, the Shanghai Medical Device Review Center immediately formed an inspection team and went to the enterprise site to carry out the work. At 7 p.m. that day, the inspection team successfully completed all the verification work.

Yang Yiqiang said, "From the perspective of system verification, early intervention and on-site coaching have proven effective."

The industry as a whole moves forward

Why Can China Take the "First" in the Global Brain-Computer Interface Race? The Answer Lies Beyond Neuracle's R&D Story.

"Shanghai has gathered a group of brain-computer interface medical device R&D companies. At least two years ago, the sub-center established a special working group for brain-computer interface medical devices to strengthen research while guiding enterprises." Li Yaohua’s words revealed the vigorous momentum of industry R&D and the determination of regulators to keep pace with the industry's development.

In fact, in recent years, the activity in China's brain-computer interface field has been evident. Numerous R&D enterprises have gathered in places like Beijing and Shanghai, seizing policy opportunities and leveraging the development advantages in local integrated circuits, artificial intelligence, biomedicine, and other fields to promote product transformation across different technical routes. The leading companies, often supported by research from relevant laboratories at universities and scientific research institutes, possess technological reserves and talent advantages, gaining the favor of capital.

At the same time, the National Medical Products Administration (NMPA) has also made forward-looking deployments. Public information shows that in September 2023, the Artificial Intelligence Medical Device Innovation Cooperation Platform established a Brain-Computer Interface Research Working Group. In addition, the standardization process has also started in advance, with the release of *Medical Device Terminology Using Brain-Computer Interface Technology* in September 2025, which unifies the "grammar" for industry communication and dialogue. This is also the world's first brain-computer interface medical device standard.

"From Zero to One" Leap, What Are the Impacts?

"The review and approval of the first product are highly beneficial for understanding matters, forming experiences, and even improving systems." A reviewer from the sub-center told reporters that the review experience of the first product serves as a reference for subsequent products of the same kind. As review experience accumulates, it can help establish guiding principles for reviews, further guiding industry research and development.

Companies in the industry are also greatly encouraged. Chen Yaoxu, General Manager Assistant of Shanghai Jieti Medical Technology Co., Ltd., said: "Everyone sees that the path for the research, development, and registration of brain-computer interface medical devices is clear and rapid." Chen Yuan, Clinical Director of Shanghai Naohoo Technology Co., Ltd., believes that the approval of the first product not only provides the industry with a clear route suggestion for obtaining certification but also strengthens the R&D confidence of some hesitant companies.

Notably, the industry is unlocking more possibilities for the clinical application of brain-computer interfaces. The multi-center clinical trial of "Beijing Brain No.1" by Beijing Xinzhide Neural Technology Co., Ltd. has been initiated. Reporters learned during interviews that both Stepped Medical and NeuraLink plan to launch large-scale multi-center clinical trials this year to advance their products towards registration.

Many technical routes in the brain-computer interface field are currently under development. What might the future of this field look like? There is currently no answer.

"Now, there are many companies developing brain-computer interface products, and the differences in indications selection are also very large." Chen Yuan introduced that companies in the industry are currently exploring applications in motor rehabilitation, language function reconstruction, and treatment of neurological diseases, broadening the development track for the brain-computer interface industry. She also hopes that during the formulation of subsequent relevant policies and regulations, requirements can be appropriately relaxed to encourage companies to explore different technical routes.

In Chen Yaoxu's view, the brain-computer interface field is still a blue ocean, requiring exploration in different directions: "The 'North Star' each company sees is different, which will lead everyone to different places."

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(Editor: Song Li)