The FDA has granted Philips 510(k) clearance for its ultrasound systems to be used to address lung and cardiac complications that arise in COVID-19 patients. The clearance encompasses the firm’s EPIQ series, Affiniti series, Lumify, CX50 and Sparq diagnostic ultrasounds, and for offerings such as the QLAB Advanced Quantification Software.
Ultrasounds can help to diagnose patients with signs of respiratory distress and portable ultrasounds, such as the Philips Lumify, can do so at the point of care. Not having to move patients around the hospital reduces the potential for disease transmission and patients entering the emergency room can be triaged more efficiently.
“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, in a press 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 US.”
The company is touting its Lumify with Reacts system, which works with smartphones or tablets to provide ultrasound and telemedicine within a compact package. Using it, clinicians can maintain two-way audio and video communication while sharing the ultrasound imaging data. This can help hospitals short on staff to partner with available physicians to help perform ultrasound examinations.