麦澜德取得江苏首张非侵入式脑机接口医疗器械注册证 引领高端医疗器械新赛道

Core Insights - The company, Mailland, has achieved a significant milestone by obtaining the medical device registration certificate for its non-invasive brain-computer interface transcranial magnetic stimulation device, becoming the first in Jiangsu Province to do so [1][2] - This achievement marks a substantial breakthrough in the field of advanced medical technology and indicates a practical step towards the industrial application of non-invasive brain-computer interfaces, opening new avenues for future technological expansion and revenue growth [1][3] Company Developments - Mailland has been actively transforming its business and iterating its technology, establishing a solid revenue base in niche medical device sectors such as pelvic floor rehabilitation and reproductive rehabilitation, while also clearly positioning itself in high-end medical technology, including brain-computer interfaces [2] - The company’s brain-computer interface product focuses on non-invasive multimodal technology, combining EEG and fNIRS signals to enhance clinical usability and signal analysis accuracy, with expectations to obtain its first medical device registration certificate by Q1 2026 [2] Industry Trends - The brain-computer interface technology is entering a critical phase of commercialization and clinical application, benefiting from national policy support, the establishment of industry standards, and continuous breakthroughs in core technologies, indicating a shift from research validation to large-scale market expansion [2] - The domestic market for brain-computer interfaces is rapidly growing, with multiple technological routes, including invasive, semi-invasive, and non-invasive methods, suggesting a future integration of medical, rehabilitation, and consumer applications [2]