Fujifilm Sonosite Receives FDA COVID-19 510(k) Clearance for POC Ultrasound Portfolio

FUJIFILM Sonosite, Inc. (Bothell, WA, USA) has received 510(k) Clearance from the US Food & Drug Administration (FDA) for its point-of-care ultrasound (POCUS) portfolio to support healthcare providers in performing accurate lung and cardiac imaging in COVID-19 patients.

Fujifilm Sonosite has also released a comprehensive user guide designed to assist healthcare professionals on how to best utilize POCUS technology to correctly interpret ultrasound images to recognize the most typical COVID-19 findings relating to lung and cardiac conditions. Clinicians can use the user guide to confirm that their selection of transducer, ultrasound system, exam type, and scan settings are appropriate for performing lung and cardiac ultrasound examinations; follow recommended protocols to properly place an ultrasound transducer on the patient in order to obtain optimal quality images; correctly interpret ultrasound images to recognize the most typical COVID-19 findings relating to lung and cardiac conditions; and review additional resources for healthcare professionals to learn of the most current COVID-19 information.


"POCUS has emerged as a critical tool to support clinicians in their tireless efforts to evaluate lung and cardiac complications of COVID-19," said Diku Mandavia, MD, FACEP, FRCPC, Senior Vice President and Chief Medical Officer of FUJIFILM Sonosite, Inc. "We're very pleased that Fujifilm Sonosite's POCUS portfolio has received this clearance from the FDA and most importantly, that our technology is contributing to helping physicians care for patients during one of the world's worst pandemics in history."

"COVID-19 patients can deteriorate rapidly in a matter of minutes to hours, and ultrasound is there and ready when we don't have minutes to spare. And while ultrasound alone doesn't tell me exactly what the disease is, it allows me to look for typical COVID-19 ultrasound findings as well as assess the disease severity to determine the optimal management plan for the patient," said Dr. Vi Dinh MD, FACEP, RDMS, RDCS, emergency medicine and critical care physician at Loma Linda University Medical Center, in Loma Linda, California. "I appreciate that point-of-care ultrasound is much safer, faster to use, and easier to sanitize than many other medical devices in the emergency department and intensive care unit. This technology is truly critical in the fight against COVID-19."