BrainCo Plans Multiple BCI Medical Devices for Regulatory Approval in 3–5 Years Amid Hong Kong IPO Filing

BrainCo, a brain-computer interface company that recently completed a new round of financing, has received approval for its products to enter the serious medical market. As a leading company in non-invasive brain-computer interfaces, this move will accelerate the application and promotion of brain-computer interface technology in the medical field.

On January 31, at the Brain-Computer Interface Diagnosis and Treatment Innovation Academic Exchange Conference and Technology Release hosted by the People's Daily Health Client and supported by BrainCo, BrainCo's ADHD (Attention Deficit Hyperactivity Disorder, commonly known as "hyperactivity") intervention product, "Focusen" medical version, officially debuted and was announced to have received approval. It is reported that this marks the world’s first realization of combined software and hardware medical device use for children's attention training, offering a new path to rehabilitation for millions of children with ADHD.

Academic Exchange Conference on Brain-Computer Interface Diagnosis and Treatment Innovation and Technology Release Event

Hope 100 Million People Experience Brain-Computer Interface Technology in the Next Decade

BrainCo Releases "Focus欣" Medical Version Attention Training System. This product is specifically designed for children aged 6 to 12 with ADHD. It consists of attention deficit and hyperactivity disorder rehabilitation training software and a single-channel prefrontal EEG collector, offering a convenient-to-use wearable EEG device that provides a medical-grade solution for auxiliary ADHD rehabilitation training in this age group.

According to the introduction, the rehabilitation training software and the prefrontal single-channel EEG collector included in the medical version of "Focus欣" have both obtained the Class II medical device registration certificate in China. This has achieved full-chain medical device compliance certification of "software + hardware" in the brain-computer interface ADHD intervention field, enabling the product to possess the practical foundation for entering the public hospital system and being included in standardized diagnosis and treatment pathways in terms of compliance and clinical compatibility, which becomes its core competitiveness.

As a落地成果 of BrainCo's non-invasive brain-computer interface technology in the field of children's neurodevelopment, "Focus欣" has established a comprehensive and in-depth patent layout, with over 70 related invention patents. The patents cover the complete technical闭环 of "signal acquisition-decoding analysis-application feedback," forming a full-chain core technology barrier from hardware design, signal processing to software content.

BrainCo Founder and CEO Han Bicheng also spoke at the conference, emphasizing that, on the technical level, "Focusen" has obtained over 70 authorized patents, establishing a systematic technical barrier. In terms of compliance, two components of BrainCo's medical products have received medical device registration certificates: the EEG collector and rehabilitation training software. Clinically, data shows that in multiple core indicators, the improvement effect of the BrainCo combination group was better than that of the drug-only group, providing doctors and parents with a reliable and sustainable tool.

Han Bicheng also shared the future development goals of BrainCo at this conference. He stated that the company will focus on the entire life cycle of human health for industrial layout in the future.

"We hope that in the next 10 years, we can help at least 1 million people with physical disabilities install neuro-controlled prosthetics, enabling them to regain their independence and step out of their homes; we also hope to assist 10 million patients suffering from ADHD, autism, insomnia, and even Alzheimer's disease to recover and start anew; we further aim to allow over 100 million people to experience brain-computer interface technology and the convenience it brings to everyday life. We will continue to work diligently on this difficult but crucial mission," said Han Bicheng.

It is reported that in the next three to five years, BrainCo's technological iteration will focus on the layout of brain health management throughout the entire life cycle. In the field of childhood neurodevelopmental disorders, in addition to the certified ADHD intervention product, the company also has a social training system for autism spectrum disorder, which helps children with autism improve their social interaction abilities through brain-computer interface technology.

In the field of age-related neurodegenerative diseases, BrainCo has extended its brain-computer interface technology to the early intervention of Alzheimer's disease. Through continuous personalized neuromodulation and cognitive training, it helps middle-aged and elderly individuals slow down the progression of cognitive decline and improve the quality of life for elderly patients.

BrainCo stated that, currently, the technical research and product development for the aforementioned issues are underway.It is expected that in the next 3-5 years, multiple brain-computer interface products targeting different brain diseases will successively obtain medical device registration certificates., building a product matrix for neural health management that covers the entire life cycle.

In terms of implementation and promotion, BrainCo will drive the下沉 of these innovative technologies to grassroots medical institutions. In the international market, BrainCo's intelligent bionic hand and intelligent bionic leg have received U.S. FDA certification and are being promoted in the U.S. market, accumulating valuable experience for the company’s brain-computer interface products entering the international market. The international certification process for related products is proceeding in an orderly manner.

BrainCo, as one of the "Hangzhou Six Dragons," is known to the outside world and is also a representative non-invasive startup company in the brain-computer interface field. However, BrainCo itself has always been very low-key and seldom speaks out.

Previously, BrainCo completed approximately 2 billion RMB in financing, marking the second-largest funding round in the brain-computer interface field globally, following Neuralink under Musk. Investors include IDG and Walden International.Lens Technology、Lingyi Intelligent Manufacturingetc.

Policy Support Accelerates the Commercialization of Brain-Computer Interface Technology

In recent years, brain-computer interface (BCI) as a "future industry" has received unprecedented policy support and market opportunities in China. In 2025, the Ministry of Industry and Information Technology and six other departments jointly issued the "Implementation Opinions on Promoting the Innovative Development of the Brain-Computer Interface Industry," explicitly including BCI as a key focus for future industrial cultivation. The "15th Five-Year Plan" proposal designated "brain-computer interface" as one of the six "future industries," marking it as a new economic growth point and providing top-level design support for industrial development.

With the support of national policies, brain-computer interface technologies are actively advancing in their commercialization processes. From the perspective of the competitive landscape, non-invasive brain-computer interface companies in China mainly adopt a "medical + consumer" dual-driven strategy. Currently, there are companies entering the market from consumer application scenarios as well as those focused on serious medical fields, but products that have obtained medical device registration certificates remain scarce. In niche areas such as ADHD, cognitive rehabilitation, and sleep disorders, companies are accelerating product registration and clinical validation. However, complete systems with both software and hardware certified as medical devices are still rare. The industry as a whole is characterized by diverging technological pathways and an accelerating commercialization process.

It is reported that at the level of medical insurance payment, in March 2025, the National Healthcare Security Administration issued the "Guidelines for the Establishment of Neurological Medical Service Price Projects (Trial)," which established for the first time the chargeable item of "Non-invasive Brain-Computer Interface Adaptation Fee." For instance, the Hubei Provincial Healthcare Security Administration introduced the first brain-computer interface medical service price project in China, specifying the non-invasive brain-computer interface adaptation fee as 966 yuan per session, providing institutional guarantees for the compliant and controlled entry of the technology into clinical practice.

Academician Wei-Hong Tan of the Chinese Academy of Sciences pointed out at this conference that brain-computer interfaces have unique advantages in building an integrated "diagnosis-treatment-rehabilitation" system in clinical settings. Under the premise of continuously improving technology and ethical standards, efforts should be accelerated to promote its transformation into clinical applications, truly serving human health.

In terms of clinical needs, the most prominent pain point currently lies in the limitations of traditional intervention methods. Take ADHD as an example: the prevalence rate of 6.4% among children and adolescents in China means that over 20 million children require intervention. However, medication treatment raises concerns about side effects, while traditional behavioral training faces issues such as long cycles, poor compliance, and insufficient primary healthcare resources. Doctors urgently need a safe, effective, and home-based intervention tool that can meet medical-grade standards while reducing the time and economic costs for families. Brain-computer interface technology provides an innovative solution to this clinical challenge by directly targeting brain function through neurofeedback training.

The clinical research shared by Professor Jin Xingming, a lifetime professor at Shanghai Children's Medical Center affiliated with the Shanghai Jiao Tong University School of Medicine, was conducted using BrainCo's non-invasive brain-computer interface product, “Focus欣” medical version. The product features a more lightweight and easier-to-wear design. Compared to traditional EEG devices, which are characterized by complex wiring, a large number of electrodes, and high operational difficulty, this product allows for faster and more convenient EEG data collection and training.

Reporter Zhou Ling from The Paper