Medical AI company Lunit announced on the 8th that it has applied for premarket approval (510(k)) from 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 approval process that demonstrates a new medical device's safety and effectiveness are equivalent to those of existing marketed products for its launch in the U.S. market. Lunit aims to obtain FDA approval by 2026.

Lunit's 'INSIGHT Risk' is software that analyzes mammography images with AI to predict the likelihood of breast cancer occurring within the next five years. Traditional risk assessment models require detailed surveys to understand family history, height, age at menarche, number of childbirths, lifestyle, etc., and have low accuracy in identifying risk groups. However, 'INSIGHT Risk' calculates individual risk with high accuracy using only mammography images and patient age, facilitating personalized cancer screening and prevention. This technology was designated as a Breakthrough Device by the FDA in April of this year.

If 'INSIGHT Risk' obtains FDA approval in the future, it is expected to enable the establishment of a comprehensive breast cancer management platform encompassing 'diagnosis-risk prediction-follow-up management' by integrating with various breast cancer management solutions, including the existing Lunit INSIGHT MMG.

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