[Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]

Brain-computer interface (BCI) medical devices represent a category of innovative medical devices. They assist in treating neurological disorders by leveraging human-machine interaction to improve patients' quality of life. Simultaneously, ultrasound is a non-invasive and effective medical physics technology. It enables imaging of cerebral hemodynamic changes and neuromodulation, specifically for acquiring brain activity information and stimulating deep brain tissues. Notably, ultrasound BCI medical devices targeting deep brain stimulation remain in the research and clinical trial phases. Consequently, ultrasound BCI technology has significant research prospects. In this paper, different types of ultrasound BCI medical device technologies are firstly summarized and organized, followed by a review of their current research status. Then, the regulatory laws and regulations for ultrasound-based BCI devices are briefly discussed, and finally the future regulatory requirements for related products are prospected.