Lunit Applies for FDA Approval of Breast Cancer Risk Prediction Solution

Image-Based Risk Assessment Model
Predicting the Likelihood of Breast Cancer Within Five Years

Lunit, a medical artificial intelligence (AI) company, announced on December 8 that it has submitted a premarket notification (510(k)) to the U.S. Food and Drug Administration (FDA) for its breast cancer risk prediction solution, "Lunit INSIGHT Risk."

The 510(k) is a representative FDA regulatory process that demonstrates a new medical device is as safe and effective as an already marketed device, and is required for launching new medical devices in the U.S. market.

Lunit INSIGHT Risk is software that analyzes mammography images using AI to predict the likelihood of developing breast cancer within the next five years. Traditional risk assessment models require detailed surveys to gather information such as family history, height, age at menarche, number of childbirths, and lifestyle habits, but have limited accuracy in identifying high-risk groups. In contrast, this solution calculates highly accurate, individualized absolute risk using only mammography images and the patient's age, enabling personalized cancer screening and prevention.

This technology was already designated as a Breakthrough Device by the FDA in April 2025. Lunit was also selected for the FDA's Total Product Life Cycle Advisory Program (TAP), allowing the company to proactively address regulatory and development challenges and refine its U.S. market entry strategy through collaboration with various stakeholders.

Last year, at the Radiological Society of North America (RSNA 2024) meeting, Lunit unveiled the risk prediction solution as its first integrated product with Lunit International and announced plans to submit for FDA approval within the year. With this FDA 510(k) submission, Lunit has officially begun the regulatory process for launching in North America as originally planned and is aiming to obtain FDA approval by 2026.

If Lunit INSIGHT Risk receives FDA approval in the future, it will be possible to build a comprehensive breast cancer care platform that covers diagnosis, risk prediction, and follow-up management by integrating with existing solutions such as Lunit INSIGHT MMG, Lunit INSIGHT DBT, and various breast cancer management solutions from Lunit International.

Seo Bumseok, CEO of Lunit, stated, "Lunit INSIGHT Risk is based on a validated risk prediction solution developed by leading authorities in breast cancer research. With this FDA approval application, we aim to build an AI ecosystem that provides integrated insights into breast cancer and redefine the paradigm of breast cancer screening."

This content was produced with the assistance of AI translation services.