Although the Segment Anything Model (SAM) has demonstrated impressive performance in 2D natural image segmentation, its application to 3D volumetric medical images reveals significant shortcomings, namely suboptimal performance and unstable prediction, necessitating an excessive number of prompt points to attain the desired outcomes. These issues can hardly be addressed by fine-tuning SAM on medical data because the original 2D structure of SAM neglects 3D spatial information. In this paper, we introduce SAM-Med3D, the most comprehensive study to modify SAM for 3D medical images. Our approach is characterized by its comprehensiveness in two primary aspects: firstly, by comprehensively reformulating SAM to a thorough 3D architecture trained on a comprehensively processed large-scale volumetric medical dataset; and secondly, by providing a comprehensive evaluation of its performance. Specifically, we train SAM-Med3D with over 131K 3D masks and 247 categories. Our SAM-Med3D excels at capturing 3D spatial information, exhibiting competitive performance with significantly fewer prompt points than the top-performing fine-tuned SAM in the medical domain. We then evaluate its capabilities across 15 datasets and analyze it from multiple perspectives, including anatomical structures, modalities, targets, and generalization abilities. Our approach, compared with SAM, showcases pronouncedly enhanced efficiency and broad segmentation capabilities for 3D volumetric medical images. Our code is released at https://github.com/uni-medical/SAM-Med3D.

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