The FDA has granted Royal Philips (NYSE:PHG) 510(k) clearance to market a wide range of its ultrasound systems to help manage 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, according to Philips.
The 510(k) clearance, which Philips called an industry first, allows the Netherlands-based company to provide detailed, practical guidance to support clinicians using its systems and software for COVID-19 patients. The clearance applies to Philips’ 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, according to Philips. 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 healthcare providers evaluate 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 or intensive care unit, 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, SVP and GM of ultrasound at Philips, in a news 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.”
Philips touts the Lumify with Reacts point-of-care ultrasound device, which works in conjunction with a compatible smartphone or tablet, as 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, according to Philips.