Lunit Nets FDA Nod for AI-Powered 3D Breast Tomosynthesis Solution, Lunit INSIGHT DBT
Summary
November 22, 2023 — Lunit, a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3D Breast Tomosynthesis (DBT) AI solution, Lunit INSIGHT DBT. DBT imaging offers a faster and more accurate breast cancer diagnosis compared to traditional 2D mammography screenings. More than 40 million mammography screenings are reported in the US annually," said Brandon Suh, CEO of Lunit. "Given this substantial market influence, achieving FDA clearance for Lunit INSIGHT DBT not only solidifies our presence in the largest market but also marks a significant milestone in our mission to revolutionize breast cancer diagnosis and, ultimately, save more lives." With this latest FDA clearance, Lunit continues its journey to bring groundbreaking AI breast imaging to the forefront of cancer diagnosis, promising a future where early detection and treatment of breast cancer becomes more accessible and accurate.
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