Leica Biosystems receives FDA’s enforcement discretion for use of Aperio ImageScope DX viewing software for remote diagnosis during Covid-19 emergency

AT2 DX

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VISTA, CA, April 3, 2020 – Leica Biosystems, the global leader in pathology workflow solutions, today announced it 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.

About Leica Biosystems
(LeicaBiosystems.com) (LeicaBiosystems.com) is a global leader in workflow solutions and automation, integrating each step in the workflow. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries and is headquartered in Nussloch, Germany.