Lunit gets FDA clearance for 3D mammography AI update

Lunit has received FDA clearance for version 1.2 of its 3D mammography AI algorithm. The company announced the clearance at the Society of Breast Imaging Annual Symposium.

The FDA clearance covers Lunit INSIGHT DBT v1.2 under 510(k) K253796. The FDA decision date was March 26.

The software is intended to aid interpreting physicians in the detection and characterization of suspected breast cancer lesions in digital breast tomosynthesis exams. It is not intended to replace physician review or clinical judgment, according to the FDA summary.

The updated version adds current-prior comparison. Lunit said the feature provides AI findings for the current exam and up to 2 prior exams.

The algorithm also includes 3 selectable thresholds to support different sensitivity and specificity trade-offs. The FDA summary states that the new version includes user-selected threshold operating points that allow clinicians to choose from 2 additional sensitivity levels.

Version 1.2 adds optional integration with external software to display volumetric breast density information for each breast. Lunit said users can access Volpara Scorecard density measures alongside AI scores.

The FDA summary also notes expanded compatibility with Siemens and Fujifilm systems, in addition to Hologic and GE HealthCare systems.

Performance testing included 3,277 DBT exams from adult female patients collected at multiple U.S. imaging facilities. The standalone ROC AUC was 0.9388, with sensitivity of 91.11% and specificity of 77.62% at the default operating point.

Lunit also said it has expanded to more than 330 screening sites across the Americas over the past year. The company said those sites support approximately 1M screening mammograms annually.