Lunit has announced the submission of a 510(k) premarket notification seeking clearance from the US Food and Drug Administration (FDA) for its breast cancer risk prediction model, Lunit INSIGHT Risk.
The model is designed to estimate a woman’s five-year risk of developing breast cancer based on screening mammograms, either digital or synthetic, without requiring patient questionnaires.
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Lunit acquired the technology, which was developed originally at Washington University School of Medicine in St Louis, US, by Dr Graham Colditz and Dr Shu (Joy) Jiang.
According to the company, it is the inaugural AI solution to provide surveillance, epidemiology, and end results (SEER)-calibrated five-year absolute risk estimates for women in the US.
Lunit anticipates that the potential clearance of the model will occur in 2026.
The performance of the model is said to have been validated in two peer-reviewed studies, showing five-year area under the curve (AUC) values of up to 0.80 across diverse screening populations in Canada and the US.
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By GlobalDataThese trials also indicated consistent performance regardless of race, age, or breast density, supporting the model’s potential for equitable adoption in clinical settings.
Lunit INSIGHT Risk received breakthrough device designation from the US regulator.
Lunit CEO Brandon Suh said: “By delivering absolute, guideline-aligned five-year risk estimates directly from routine screening images, Lunit INSIGHT Risk aims to support earlier and more informed decisions in preventive care. We believe this approach can help health systems implement practical risk-stratified strategies as screening recommendations continue to evolve.
“As screening programmes increasingly shift from a one-size-fits-all approach to more personalised, risk-informed pathways, we see this submission not only as a scientific milestone but also as a strategic step that positions Lunit to meet the changing needs of health systems and patients.”
The model is intended to work alongside Lunit’s breast health portfolio, including Lunit INSIGHT MMG and DBT detection models, as well as Volpara RiskPathways.
This integration aims to support risk-based workflows across evaluation, imaging, reporting, and ongoing follow-up.
In September 2025, Lunit entered a partnership with Canada-based research organisation CellCarta to integrate digital pathology AI into clinical trials.
