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BioWorld - Tuesday, March 3, 2026
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Home » Lunit gains FDA nod for AI-powered breast cancer diagnostic tool
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Lunit gains FDA nod for AI-powered breast cancer diagnostic tool

Nov. 15, 2023
By Marian (YoonJee) Chu
Lunit Inc. is the latest South Korean firm to gain the U.S. FDA’s 510(k) clearance for Lunit Insight DBT, its artificial intelligence (AI)-powered breast cancer diagnostic tool that analyzes digital breast tomosynthesis (DBT) images, boosting its efforts to enter the U.S. market. The company also reported that it secured $150 million in a public offering.
Medical technology Regulatory Artificial intelligence Cancer U.S. FDA

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