FDA’s enforcement discretion allowing to expand remote use of Philips IntelliSite Pathology Solution during COVID-19 emergency

April 2, 2020
Intention to exercise enforcement discretion due to COVID-19 emergency by the U.S. Food and Drug Administration (FDA) provides extra flexibility to U.S. pathologists to work from homeAmsterdam, The Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, announced that the FDA has granted a waiver for the use of readily available consumer monitors at home with the Philips IntelliSite Pathology Solution [1]. Pathologists, who may not be able to work on-site due to the current COVID-19 emergency, can start working from home to review pathological cases and so prevent any delay in critical patient care.Pathologists play a crucial role in the detection and diagnosis of a broad range of diseases, including cancer, and consequently guide treatment decisions. The already scarce resources of pathologists are under enormous pressure to maintain high-quality patient care. Recently, both pathologists’ societies and industry associations successfully advocated a waiver from remote pathology restrictions during this public health pandemic.  “While the Philips IntelliSite Pathology Solution has been used over the past three years for remote work with a medical-grade monitor, we welcome the FDA exemption to allow consumer monitors to be used immediately by pathologists with our Solution,” said Marlon Thompson, General Manager of Philips Digital & Computational Pathology. “This enables more pathologists to work from home with the same confidence that they have in the office.”Exemption
The FDA temporarily exempts restrictions for the remote use of the Philips IntelliSite Pathology Solution from March 28, 2020, onwards under specific conditions and device specifications. Pathologists are allowed to access whole slide images of patient tissue remotely through a secure VPN high-speed internet connection. And using a viewing web-based browser and monitor meeting specified minimum requirements, they can make a definitive diagnosis of histology cases from their home office.End-to-end digital pathology solution
Philips IntelliSite Pathology Solution is designed for in-vitro diagnostic purposes, helping pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue samples. It has market access clearance in over sixty countries, including the USA. Visit the Philips website for detailed information on the deployment of Philips IntelliSite Pathology Solution for remote use.[1] Remote use of Philips IntelliSite Pathology Solution in the USA are under specific conditions and device specifications. The limitations and warnings specified in device labeling are still applicable to this situation.
* Outside the U.S. monitors are not part of the Philips IntelliSite Pathology Solution, and consumer monitors meeting minimum specifications can be used.For further information, please contact:Hans Driessen
Philips Global Press Office
Tel. : +31 6 10610417
E-mail: hans.driessen@philips.com
Twitter: @hansdriessen_phAbout Royal Philips