从消费电子到医疗器械：强脑科技“专注欣”医疗版获批，加速商业化转型

Core Insights - Strong Brain Technology has announced that its ADHD intervention product "Focus Xin" has received medical device registration in China, becoming the world's first brain-computer interface product for children with ADHD to obtain joint certification for both software and hardware [1][4] - This approval marks a significant step in the clinical application of non-invasive brain-computer interface technology, providing evidence-based non-drug rehabilitation options for approximately 23 million children with ADHD in China [1][4] Product Overview - "Focus Xin" consists of a rehabilitation training software for ADHD and a single-channel EEG collector, utilizing non-invasive brain-computer interface technology based on neurofeedback mechanisms [3] - The product allows users to wear a lightweight headband to collect EEG signals, with the system analyzing attention status in real-time and guiding children through attention training via gamified tasks [3] - Compared to traditional multi-channel EEG devices, "Focus Xin" offers advantages such as lightweight design, ease of use, and lower operational barriers, enhancing its feasibility for home and grassroots medical institutions [3] Clinical Validation - The clinical efficacy of "Focus Xin" has been validated through rigorous studies, showing significant improvements in children's attention, self-control, and executive function [3] - Research indicates that the product's effects are more pronounced when used in conjunction with medication, particularly for younger children aged 6-7 [3] Market Context - The prevalence of ADHD in China is approximately 6.4%, with a total patient population of around 23 million, but the current treatment rate is below 10%, indicating a substantial treatment gap [4] - Existing mainstream medication treatments have limitations, such as poor adherence, noticeable side effects, and high relapse rates after discontinuation, highlighting the need for non-drug interventions like "Focus Xin" [4] - The Chinese ADHD treatment market was valued at approximately 8.3 billion yuan in 2023, with projections to exceed 34 billion yuan by 2030, indicating a growing market for digital therapies [4] Company Background - Strong Brain Technology was founded in 2015 by Han Bicheng, focusing on the development of non-invasive brain-computer interface technology [4] - The company has established three product lines: intelligent bionics, smart health, and smart education, and completed a 2 billion yuan equity financing round in January 2026, with a valuation exceeding 1.3 billion USD [4] - The approval of "Focus Xin" signifies the company's strategic shift from consumer products to compliant medical products, establishing high entry barriers and laying the foundation for commercial replication [4] Future Implications - The certification of "Focus Xin" allows it to enter hospital procurement systems and opens possibilities for future integration with health insurance and commercial insurance [5] - Experts emphasize the unique advantages of brain-computer interface technology in creating an integrated system for diagnosis, treatment, and rehabilitation, advocating for collaborative mechanisms among hospitals, enterprises, schools, and communities to promote the technology's widespread application [5] - The approval of "Focus Xin" not only represents a milestone for Strong Brain Technology but also provides a replicable model for the medicalization of brain-computer interface technology, with potential for digital therapies to reshape the treatment paradigm for children's neurodevelopmental disorders [5]