Foundational models have emerged as powerful tools for addressing various tasks in clinical settings. However, their potential development to breast ultrasound analysis remains untapped. In this paper, we present BUSGen, the first foundational generative model specifically designed for breast ultrasound image analysis. Pretrained on over 3.5 million breast ultrasound images, BUSGen has acquired extensive knowledge of breast structures, pathological features, and clinical variations. With few-shot adaptation, BUSGen can generate repositories of realistic and informative task-specific data, facilitating the development of models for a wide range of downstream tasks. Extensive experiments highlight BUSGen's exceptional adaptability, significantly exceeding real-data-trained foundational models in breast cancer screening, diagnosis, and prognosis. In breast cancer early diagnosis, our approach outperformed all board-certified radiologists (n=9), achieving an average sensitivity improvement of 16.5% (P-value<0.0001). Additionally, we characterized the scaling effect of using generated data which was as effective as the collected real-world data for training diagnostic models. Moreover, extensive experiments demonstrated that our approach improved the generalization ability of downstream models. Importantly, BUSGen protected patient privacy by enabling fully de-identified data sharing, making progress forward in secure medical data utilization. An online demo of BUSGen is available at https://aibus.bio.

During ultrasonic scanning processes, real-time lesion detection can assist radiologists in accurate cancer diagnosis. However, this essential task remains challenging and underexplored. General-purpose real-time object detection models can mistakenly report obvious false positives (FPs) when applied to ultrasound videos, potentially misleading junior radiologists. One key issue is their failure to utilize negative symptoms in previous frames, denoted as negative temporal contexts (NTC) [15]. To address this issue, we propose to extract contexts from previous frames, including NTC, with the guidance of inverse optical flow. By aggregating extracted contexts, we endow the model with the ability to suppress FPs by leveraging NTC. We call the resulting model UltraDet. The proposed UltraDet demonstrates significant improvement over previous state-of-the-arts and achieves real-time inference speed.