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FDA Clears Digital Pathology System From Leica Biosystems

NEW YORK (360Dx) – Danaher's Leica Biosystems said today that the US Food and Drug Administration has cleared its Aperio AT2 DX System for clinical diagnosis in the US.

The Aperio AT2 DX System is a high-throughput automated scanning and viewing platform. Vista, California-based Leica said that it will be launched with clinical image management software for an integrated digital pathology workflow solution.

The digital pathology system can be used for primary diagnosis as a result of the 510(k) clearance, which followed a multicenter study conducted at five clinical sites — the University of California, Davis; Pacific Rim Pathology; Dignity Health; TriCore Reference Laboratories; and Intermountain Healthcare. In the study, which examined 16,000 cases of whole-slide images, pathology slides read under the microscope were compared with on-screen digital reads.