FDA's enforcement discretion allowing to expand remote use of Philips IntelliSite Pathology Solution during COVID-19 emergenc...
April 02 2020 - 9:00AM
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 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," 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."
ExemptionThe 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 DriessenPhilips Global Press OfficeTel. : +31 6
10610417E-mail: hans.driessen@philips.comTwitter:
@hansdriessen_ph
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.
- Pathologists work from home to review pathological cases
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