Lunit Submits 510(k) Application for Image-Based Breast Cancer Risk Prediction Model

Lunit seeks FDA clearance for breast cancer risk prediction model

Lunit has announced the submission of a 510(k) premarket notification seeking clearance from the US FDA for its breast cancer risk prediction model.The post Lunit seeks FDA clearance for breast cancer risk prediction model appeared first on Medical Device Network.

Lunit Submits 510(k) Application for Image-Based Breast Cancer Risk Prediction Model

Lunit logo Lunit, a leading provider of AI for cancer diagnostics and precision oncology, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for Lunit INSIGHT Risk, a mammography-based five-year breast cancer risk prediction model. Potential clearance is expected in 2026. Lunit INSIGHT Risk estimates a woman's five-year breast cancer risk directly from screening mammograms (either…