Lunit has received clearance from the U.S. Food and Drug Administration (FDA) for version 1.2 of its 3D mammography AI algorithm. The announcement was made at the Society of Breast Imaging (SBI) Annual Symposium in Seattle.
The updated algorithm introduces current-prior comparison and multiple operating thresholds to its Insight breast imaging platform. It provides AI findings for the current exam and up to two prior exams, and offers three selectable thresholds to support different sensitivity and specificity trade-offs, the company said. This version also integrates Volpara Scorecard volumetric breast density measures alongside AI scores.
Lunit also highlighted a milestone at SBI 2026, noting that it has expanded to more than 330 screening sites across the Americas over the past year -- equal to supporting approximately one million screening mammograms annually, the firm said.
![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)
