Lunit secures CE Mark for 3D breast tomosynthesis

By staff writers

March 24, 2023 -- Artificial intelligence (AI) software developer Lunit has secured the CE Mark under Europe's medical device regulation for its AI software for digital breast tomosynthesis, Lunit Insight DBT.

Medical device regulation certification is more stringent than the existing medical device directive certification, the company said. It plans to pursue clearance for the software from the U.S. Food and Drug Administration in the third quarter of this year.

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