Clearance allows for applications for lung and cardiac complications.
Royal Philips announced Wednesday has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its ultrasound solutions for the management of COVID-19-related lung and cardiac complications.
This clearance allows Philips to provide detailed guidance to clinicians using its systems and software to render point-of-care services in the emergency department or the ICU. It applies to EPIQ series, Affiniti series, Lumify, CX50, and Sparq diagnostic ultrasound systems, as well as off-cart solutions, such as QLAB Advanced Quantification Software.
According to a company statement, the new guidance highlights the specific presets, transducers, quantification tools, and other capabilities that can help assess and manage COVID-19-related lung and heart complications. Additionally, the Lumify system offers two-way audio-visual calls with live ultrasound streaming that lets both parties discuss and look at the same scan simulatenously, potentially reducing the risk of viral transmission.
“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 manage 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 U.S.”