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Doctors read each case with and without the software, and three breast imaging experts set the reference by consensus. Lesion-level sensitivity was 87.32% with the software and 66.20% without it. Subject-level specificity was 73.51% with the software and 70.70% without it, which met the non-inferiority test. On 3 January 2023, CMDE concluded that “该产品临床使用受益大于风险” (the product's clinical benefits outweigh its risks) and recommended approval. As long-term safety and effectiveness still needed follow-up, it recommended that Deepwise keep studying how well the algorithm generalizes and analyze the product's use every year. 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CQZ2200165, applicant 杭州深睿博联科技有限公司. 3 January 2023. 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