Korea-based Lunit announces that it has secured U.S. FDA 510(K) clearance for its 3D breast tomosynthesis (DBT) AI solution, Lunit Insight DBT. This clearance opens the door for Lunit to fully enter the U.S. breast screening market.
Lunit Insight DBT is an artificial intelligence algorithm specifically designed to analyze 3D images produced by DBT equipment. According to the company, DBT imaging provides faster and more accurate breast cancer diagnoses compared to traditional 2D mammography screenings.
“The US is the biggest player in the global breast screening market, accounting for up to 40% of the market share. More than 40 million mammography screenings are reported in the US annually,” says 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 FDA clearance, Lunit continues its journey to bring AI breast imaging to the forefront of cancer diagnosis, moving toward a future where early detection and treatment of breast cancer becomes more accessible and accurate.
This FDA clearance follows Lunit’s previous achievements in November 2021, when it received FDA clearance for its chest X-ray triage solution, Lunit Insight CXR Triage and for its AI-powered mammography analysis solution, Lunit Insight MMG. In addition, Lunit Insight DBT has been cleared for Europe by being CE-marked under Europe’s latest Medical Device Regulation since March 2023.
Lunit is a deep learning-based medical AI company focused on developing AI solutions for precision diagnostics and therapeutics. Lunit is devoted to developing advanced medical image analytics and AI-based biomarkers via advanced technology.