An FDA-cleared AI tool for breast ultrasound may reduce unnecessary biopsies of benign breast lesions by about 60%.
Key Details
- 1Research presented at RSNA 2025 evaluated the Koios DS AI tool for breast ultrasound.
- 2The study involved 14 breast imaging radiologists and 271 lesions in 253 women, with 76.8% benign and 23.2% malignant lesions.
- 3The AI tool showed 60.6% specificity, assigning many benign lesions to lower BI-RADS categories, and a sensitivity of 90.5%.
- 4The tool misclassified 6 malignant lesions, most of which had other imaging correlates.
- 5Experts emphasized the AI should be used as an adjunct, not a replacement, to radiologist judgment for biopsy decisions.
Why It Matters

Source
AuntMinnie
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