Image analysis software developer Quantitative Insights has received U.S. Food and Drug Administration (FDA) clearance for QuantX Advanced, a breast imaging computer-aided diagnosis platform that utilizes artificial intelligence (AI) technology.
Based on machine learning and analytics, QuantX features tools such as QI Score and Similar Case Database Compare, which give users access to a database of breast abnormalities for comparison with known pathology, the company said. The software includes technology licensed from the research labs of Maryellen Giger, PhD, of the University of Chicago. She serves as a scientific advisor for the firm.
Quantitative Insights is now seeking distribution partnerships for both the U.S. and internationally.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
