Leica Biosystems Receives FDA Enforcement Discretion of Remote Diagnosis System

Leica Biosystems has received notification from the U.S. Food & Drug Administration (FDA) that its Aperio ImageScope DX Viewer with images acquired on the Aperio AT2 DX Scanner can be used for remote diagnosis under emergency use. This application will allow Pathologists to safely view and diagnose Pathology cases from remote locations in response to the COVID-19 pandemic.

"In this time of critical need due to the COVID-19 pandemic, the Aperio AT2 DX system, including remote use of the Aperio ImageScope DX viewer, will allow pathologists to maintain a high standard of care, but now from remote locations using a digital pathology workflow," said Keith Wharton, M.D., Ph.D., FCAP, Senior Medical Director of Leica Biosystems.

"This remote use capability will be transformative — and help alleviate the pressure that the emergence of the COVID-19 outbreak has put on healthcare facilities," stated Melissa Aquino, President of Leica Biosystems.

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