Philips receives FDA clearance for the use of its ultrasound portfolio to manage COVID-19-related lung and cardiac complicati...
May 13 2020 - 9:00AM
Philips receives FDA clearance for the use of its ultrasound
portfolio to manage COVID-19-related lung and cardiac complications
May 13, 2020
Philips’ ultrasound portfolio, including Lumify with Reacts
handheld tele-ultrasound solution, provides valuable diagnostic
insight for front-line care providers
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG,
AEX: PHIA), a global leader in health technology, today announced
that it has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to market a wide range of its ultrasound
solutions for the management of COVID-19-related lung and cardiac
complications. Handheld and portable ultrasound solutions in
particular have become valuable tools for clinicians treating
COVID-19 patients due to their imaging capabilities, portability
and ease of disinfection. As a result of this regulatory clearance,
which is an industry first, Philips can provide detailed, practical
guidance to support clinicians using its systems and software for
patients affected by COVID-19. The clearance applies to Philips
ultrasound systems including the EPIQ series, Affiniti series,
Lumify, CX50 and Sparq diagnostic ultrasound systems, and to
off-cart solutions like QLAB Advanced Quantification Software.
Ultrasound has shown value in imaging peripheral lung tissue
affected by pneumonia, which is closely tied to COVID-19 lung
complications. As respiratory strain can also lead to cardiac
dysfunction, COVID-19 patients are at increased risk for cardiac
complications. A cardiac ultrasound exam can help in evaluating the
effects that disease progression may have on heart function. By
imaging COVID-19 patients at the point of care, such as in the
Emergency Department (ED) or Intensive Care Unit (ICU), clinicians
can diagnose and monitor patients without the need to move them
around the hospital, helping to reduce the risk of virus
transmission to other patients or to healthcare professionals.
“Many healthcare providers have told us that our handheld and
portable ultrasound solutions are playing a valuable role in their
efforts to combat COVID-19,” said Bich Le, Senior Vice President
and General Manager Ultrasound at Philips. “With this regulatory
clearance we can offer clear guidance to ensure safe and effective
use of ultrasound to manage COVID-19-related lung and cardiac
complications. At the same time, we are investing significantly to
ramp up production globally, including at our ultrasound
manufacturing plants in the US.”
With its broad portfolio, leadership in areas including
cardiac ultrasound and the unique capabilities of the Lumify with
Reacts handheld tele-ultrasound solution, Philips is well
positioned to support healthcare providers with ultrasound
solutions as they combat the pandemic. The Lumify with Reacts
point-of-care ultrasound solution, which works in conjunction with
a compatible smartphone or tablet, is the world’s first
ultra-portable ultrasound device with advanced telehealth
capabilities. The Reacts communications platform enables two-way
audio-visual calls with live ultrasound streaming, so both parties
can simultaneously view the live ultrasound image and probe
positioning, while discussing and interacting at the same time. In
the context of COVID-19, this solution can help minimize the risk
of virus transmission for the medical team.
The new guidance highlights the specific presets, transducers,
quantification tools and other capabilities available on Philips’
ultrasound systems that are relevant in assessing and managing
COVID-19-related lung and cardiac complications. For example, the
EPIQ CVx premium cardiology ultrasound system includes automated
applications for 2D assessment of the heart, as well as robust 3D
right ventricle volume and ejection fraction measurements.
The regulatory clearance includes the following Philips
ultrasound systems: EPIQ series, Affiniti series, Lumify, CX50, and
Sparq diagnostic ultrasound systems and off-cart solutions like
QLAB Advanced Quantification Software. More information on how
Philips is responding to COVID-19 can be found on the company’s
global newscenter.
For further information, please contact:
Mark GrovesPhilips Global Press OfficeTel: +31 631 639 916
Email: mark.groves@philips.com Twitter: mark_groves
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 81,000
employees with sales and services in more than 100 countries. News
about Philips can be found at www.philips.com/newscenter.
- Philips EPIQ CVx cardiovascular ultrasound system
- Philips Lumify with Reacts
- Philips Lumify with Reacts including patient
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