Philips Receives FDA Clearance for Use of Ultrasound Portfolio to Manage COVID-19 Complications

Philips Healthcare (Amsterdam‎, Noord-Holland) has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its ultrasound solutions for the management of COVID-19-related lung and cardiac complications.

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. Philips’ Lumify with Reacts handheld, point-of-care tele-ultrasound solution works in conjunction with a compatible smartphone or tablet and is 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. 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. In the context of COVID-19, this solution can help minimize the risk of virus transmission for the medical team.

As a result of this regulatory clearance, which is an industry first, Philips can provide detailed, practical guidance to support clinicians using its systems and software for patients affected by COVID-19. 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 lung and cardiac 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.

“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.”