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Medical Devices / Submissions and Approvals

FDA Clears Leica Biosystems’ Digital Pathology System

June 5, 2019
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The FDA granted Leica Biosystems 510(k) clearance for its Aperio AT2 DX system, an automated scanning and viewing platform.

The high-throughput device automatically scans pathology slides, delivering whole images quickly. It also allows the user to view the slides through the device.

The platform will be coupled with clinical management software to serve as an integrated digital pathology workflow solution upon launch, the company said.

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