“… 2 3 In particular, diagnostic AI in radiology, a prominent field within medical AI, now not only provides robust performance but is also becoming a part of actual clinical practice, shaking up the global medical device market. 4 5 Diagnostic AI is expanding beyond the imaging modality with remarkable AI-based SaMDs, such as real-time mortality prediction tools for general ward patients using vital signs and clinical data, 6 and real-time electrocardiogram-based myocardial infarction prediction software. 7 …”