Technology | Digital Pathology | May 29, 2019

Digital pathology system cleared for primary diagnosis following multi-center study at five clinical sites in the U.S.

Leica Biosystems Receives FDA Clearance for Aperio AT2 DX Digital Pathology System

May 29, 2019 — Leica Biosystems has received clearance from the U.S. Food and Drug Administration (FDA) to market its Aperio AT2 DX System for clinical diagnosis in the U.S.

A multi-center study supporting this clearance was conducted with pathologists at five clinical study sites in the U.S.:

  • University of California Davis;

  • Pacific Rim Pathology;

  • Dignity Health;

  • TriCore Reference Laboratories; and

  • Intermountain Healthcare.

One of the largest clinical concordance studies ever completed on digital whole slide images, the participating pathologists read approximately 16,000 cases. The study compared reads of pathology slides under a microscope with on-screen digital reads.  

The Aperio AT2 DX System is a high-throughput automated scanning and viewing platform. The platform will be launched commercially with clinical image management software for an integrated digital pathology workflow solution.

For more information: www.leicabiosystems.com

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