www.fdanews.com/articles/197146-fda-clears-philips-ultrasound-products-for-managing-covid-19-complications
FDA Clears Philips Ultrasound Products for Managing COVID-19 Complications
May 15, 2020
Philips received 510(k) clearance from the FDA for a range of ultrasound products for use in managing heart and lung complications in COVID-19 patients.
The products cleared include the company’s EPIQ and Affiniti series, Lumify, and its CX50 and Sparq diagnostic ultrasound systems.
Based on the FDA clearance, Philips is issuing specific guidance on the capabilities of the different systems for assisting COVID-19 patients.