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Lunit Nets FDA Approval for AI-Enhanced 3D Breast Tomosynthesis: Introducing Lunit INSIGHT DBT

Wednesday, November 15, 2023

Lunit, a prominent player in the realm of AI solutions for cancer diagnostics and therapeutics, has recently gained FDA 510(k) clearance for its AI solution, Lunit INSIGHT DBT, designed for 3D Breast Tomosynthesis. This development marks a significant stride in the ongoing battle against breast cancer, paving the way for Lunit's comprehensive entry into the US breast screening market. Lunit INSIGHT DBT employs AI algorithms to analyze 3D images produced by DBT equipment, presenting a quicker and more accurate diagnosis compared to traditional 2D mammography.

The precision of DBT in conducting breast cancer examinations has led to heightened demand, particularly from advanced US medical institutions, accounting for over 64% of the global demand for DBT. As of November 2023, 88% of the 8,850 facilities certified by the Mammography Quality Standards Act and Program (MQSA) in the US are equipped with DBT. This FDA clearance underscores Lunit's dedication to advancing AI-powered breast imaging for improved cancer diagnosis, promising a future where early detection and treatment of breast cancer are both more accessible and precise.

This regulatory milestone follows Lunit's earlier FDA clearances in November 2021, wherein approval was granted for its chest X-ray triage solution, 'Lunit INSIGHT CXR Triage,' and its AI-powered mammography analysis solution, 'Lunit INSIGHT MMG.'