Royal Philips has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19-related cardiac and lung complications.
Handheld and portable ultrasound solutions have become valuable tools for clinicians treating COVID-19 patients due to their imaging capabilities, portability and ease of disinfection, Philips said in a press release. As a result of this regulatory clearance, 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.
As respiratory strain can also lead to cardiac dysfunction, COVID-19 patients are at increased risk for cardiac complications, Philips noted in its press release. 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.”
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 cardiac and lung 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.