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

Submission marks a key regulatory milestone toward bringing SEER-calibrated, imaging-based risk assessment to U.S. screening programs

SEOUL, South Korea, Dec. 8, 2025 /PRNewswire/ -- Lunit (KRX: 328130), 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 synthetic or digital mammography) without the need for patient questionnaires. The technology was originally developed at Washington University School of Medicine in St. Louis by Dr. Graham Colditz and Dr. Shu (Joy) Jiang, and later acquired by Lunit.
It is the first AI solution to generate SEER-calibrated five years absolute risk estimates for U.S. women. For example, a 5 percent risk indicates that 5 of 100 women with similar risk profiles are expected to develop breast cancer within the next five years.

The model's performance has been validated in two peer-reviewed studies published in JAMA Network Open and JCO Clinical Cancer Informatics, showing discriminative performance with 5-year AUCs up to 0.80 across diverse screening populations in the U.S. and Canada. These studies also showed consistent performance regardless of age, race, or breast density, supporting its potential for equitable clinical adoption.

"Image-based risk assessment represents an important step toward making breast cancer prevention more precise and more accessible," said Graham Colditz, MD, DrPH, Professor of Washington University School of Medicine in St. Louis. "Our research has shown that mammography-derived five-year absolute risk can be both highly discriminative and well calibrated to U.S. disease incidence rates, allowing clinicians to identify women who may benefit most from supplemental screening or preventive strategies. With Lunit advancing this technology toward regulatory review, we have an opportunity to bring evidence-based, personalized risk prediction closer to routine clinical practice."

The model received FDA Breakthrough Device Designation last April and Lunit had been participating in the FDA Total Product Lifecycle Advisory Program (TAP), which enables more structured and frequent engagement with the agency during development and review. The program also supports discussions with non-FDA stakeholders to expedite market adoption, clinical use, and patient access.

"Submitting our first 510(k) for an image-based risk prediction model is an important milestone for Lunit and for the advancement of personalized breast cancer screening," said Brandon Suh, CEO of Lunit. "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 programs increasingly shift from a one-size-fits-all approach to more personalized, 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."

Lunit INSIGHT Risk is designed to integrate with the company's broader breast health portfolio, including Lunit INSIGHT MMG and DBT detection models and Volpara Risk Pathways, creating a comprehensive foundation for risk-informed care workflows that span assessment, imaging, reporting, and longitudinal follow-up.

About Lunit

Founded in 2013, Lunit (KRX: 328130) is a global leader on a mission to conquer cancer through AI. Our clinically validated solutions span medical imaging, breast health, and biomarker analysis—empowering earlier detection, smarter treatment decisions, and more precise outcomes across the cancer care continuum.

Lunit offers a comprehensive suite spanning risk prediction and early detection to precision oncology. Our FDA-cleared Lunit INSIGHT suite and breast health solutions support cancer screening in thousands of medical institutions worldwide, while the Lunit SCOPE platform is used in research partnership with global pharma and laboratory leaders for biomarker research, and companion diagnostic development.

Trusted by over 10,000 sites in more than 65 countries, Lunit combines deep medical expertise with continuously evolving datasets to deliver measurable impact—for patients, clinicians, and researchers alike. Headquartered in Seoul with global offices, Lunit is driving the worldwide fight against cancer. Learn more at lunit.io/en.

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SOURCE Lunit