Abstract: 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 devices targeting deep brain stimulation remain in the research and clinical trial phases. Consequently, ultrasound BCI technology has significant research prospects. Different types of ultrasound-based BCI medical device technologies were summarized and organized, followed by a review of their current research status. Finally, the regulatory laws and regulations for ultrasound-based BCI devices were briefly discussed, and the future regulatory requirements for related products were prospected.