ITS-200 helped sonographers spot more malignant thyroid nodules

What happened

Maide Intelligent Technology (Wuxi) built ITS-200, software whose deep learning module flags suspected malignancy in thyroid nodules of 5 mm or more. The sonographer first outlines each nodule by hand on an ultrasound image. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a prospective randomized controlled trial at five sites with surgical pathology as the reference. It enrolled 931 subjects, and 763 with paraffin pathology entered the main analysis. Nodule-level sensitivity was 97.33% with the software and 79.30% without, a difference of 18.03% (95% CI 14.57% to 21.61%). Case-level specificity was 94.19% against 75.93%. No adverse event was related to the device. On 6 March 2025, CMDE concluded from the applicant's file that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). It recommended approval. The report gives the same figures for the software alone as for the assisted sonographers. It does not say whether the prompts changed any patient's care.