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Philips, Leica Biosystems Receive Remote Digital Pathology FDA Waivers During Coronavirus Pandemic

NEW YORK – Royal Philips and Danaher's Leica Biosystems both announced this week that they have received enforcement discretion from the US Food and Drug Administration allowing pathologists to use their technology to work remotely during the coronavirus pandemic.

The agency granted waivers for using consumer monitors at home with the Philips IntelliSite Pathology Solution and for Leica Biosystem's Aperio ImageScope DX Viewer, with images acquired on the Aperio AT2 DX Scanner. Under the waiver, pathologists can access whole-slide images of patient tissue remotely through a secure VPN high-speed internet connection.

The Philips solution has been used for remote work with medical-grade monitors for the last three years, the company said.

Last month, the Centers for Medicare and Medicaid Services granted a temporary waiver allowing pathologists to review slides remotely during the SARS-CoV-2 pandemic.