Apr 02, 2020

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

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 home

Amsterdam, 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. This enables more pathologists to work from home with the same confidence that they have in the office..

Marlon Thompson

General Manager of Philips Digital & Computational Pathology

"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.

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 80,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.