Lunit submits 510(k) to U.S. FDA for breast cancer risk prediction model

AI firm Lunit has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for Insight Risk, a mammography-based five-year breast cancer risk prediction model.

The model estimates a woman's breast cancer risk from screening mammograms (either synthetic or digital). The technology was developed at Washington University School of Medicine in St. Louis, MO.

The FDA conferred Breakthrough Device Designation for the model in April, Lunit said. It has been participating in the FDA's Total Product Lifecycle Advisory Program (TAP), which allows for more structured and frequent engagement with the agency during development and review, according to the firm.

Insight Risk is designed to integrate with the company's breast health portfolio, including its Insight MMG and DBT detection models and Volpara Risk Pathways.