Ultrasound systems net clearance for management of lung, CV complications of COVID-19
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Philips announced that it has received 510(k) clearance from the FDA to market its ultrasound solutions portfolio for the management of lung and cardiac complications associated with COVID-19.
According to a press release, Philips will be able to provide practical guidance to clinicians using its systems and software (EPIQ series, Affiniti series, Lumify, CX50, Sparq and QLAB Advanced Quantification Software, Philips) which will include mobile and handheld imaging solutions for patients affected by COVID-19. The FDA clearance highlights specific presets, transducers, quantification tools and other capabilities available on Philips’ ultrasound systems.
Ultrasound imaging of peripheral lung tissue has shown utility for those affected by pneumonia, which is closely tied to COVID-19 lung complications, according to the release. Patients with COVID-19 are also at increased risk for CV complications. An ultrasound exam may help evaluate the effects of disease progression on cardiac function, the company stated in the release.
According to the release, by performing ultrasound on patients with COVID-19 in the ED or ICU, clinicians may be able to diagnose and monitor patients without the need to move them around the hospital, reducing the risk for disease transmission.
“Many health care providers have told us that our handheld and portable ultrasound solutions are playing a valuable role in their efforts to combat COVID-19,” Bich Le, senior vice president and general manager of ultrasound at Philips, said in the release. “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 U.S.”
Disclosure: Le is an employee of Philips.
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