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FDA enforcement discretion now includes Aperio WebViewer

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May 4, 2020—Leica Biosystems announced it has received additional notification from the 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 the Aperio AT2 or Aperio AT2 DX digital pathology scanners during the COVID-19 emergency. This application will allow pathologists 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,” Melissa Aquino, president of Leica Biosystems, said in a press release. “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.”

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