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 …