Amsterdam-based Royal Philips has received 510(k) clearance from the FDA to market 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.
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.
“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,” says Bich Le, senior vice president and general manager of 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 United States.”
Philips has also provided online guidance to support clinicians using its systems and software for patients affected by COVID-19.
For more information visit Royal Philips.
Featured image: Philips Lumify with Reacts