Date: 28-Apr-2020

US FDA Expands Leica Biosystems Enforcement Discretion Enabling Remote Diagnosis Using Aperio WebViewer & Aperio AT2 DX Scanners During COVID-19 Crisi

Leica Biosystems, the global leader in pathology workflow solutions, announced it has received additional notification from the US 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 US.”

“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