Ultrasound developer Fujifilm SonoSite has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the use of its point-of-care ultrasound (POCUS) for performing lung and cardiac imaging of COVID-19 patients.
In announcing the clearance, Fujifilm Sonosite notes that POCUS has emerged as a portable, efficient tool for examining patients suspected of having COVID-19 at the point of care. The 510(k) clearance applies to the company's entire POCUS portfolio.
In conjunction with the FDA's move, the company released a user guide to help healthcare providers in how to best use POCUS to interpret ultrasound images to recognize the most common COVID-19 findings with respect to lung and cardiac conditions.