FDA expands Leica Biosystems enforcement discretion enabling remote diagnosis using Aperio WebViewer and Aperio AT2 scanners during Covid-19 crisis

Leica Biosystems Aperio FDA Enforcement Discretion

Leica Biosystems recently received FDA's enforcement discretion for remote use of its Aperio digital pathology solution during the COVID-19 emergency. Now, pathologists can safely view and diagnose cases from remote locations.

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VISTA, CA April 24, 2020 – Leica Biosystems, the global leader in pathology workflow solutions, today announced it has received additional notification from the U.S. Food & Drug Administration (FDA) about its intention to exercise enforcement discretion when the Aperio WebViewer, a web-based viewing software within Aperio eSlide Manager, is used for remote diagnosis with images acquired on either Aperio AT2 or Aperio AT2 DX digital pathology scanners during the COVID-19 emergency. In response to the COVID-19 pandemic, this application will allow Pathologists maximum flexibility to safely view and diagnose Pathology cases from remote locations, including home offices, using a consumer PC and monitor.

“Keeping our customers safe during the COVID-19 response while also enabling them to maintain a high standard of patient care is the number one priority for us right now,” stated Melissa Aquino, President of Leica Biosystems. “This application will provide safe and flexible options for Pathologists as the Aperio WebViewer operates seamlessly with any of the Aperio AT2 digital pathology systems already installed in hundreds of Pathology laboratories across the U.S.”

“Pathologists working remotely need to access high performance imaging tools when rendering a diagnosis. The Aperio WebViewer plus the Aperio AT2 provides the must-have tools we need to deliver the best and most accurate care for our patients, while also ensuring our safety,” stated Eric F. Glassy, M.D., Medical Director, Affiliated Pathologists Medical Group, Affiliate Pathologist.

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.