FujiFilm Receives FDA 510(k) Clearance for Sonosite Point-of-Care Ultrasound with COVID-19 Patients

September 6, 2020

This clearance applies to lung and cardiac imaging in patients with viral infection.

Fujifilm Healthcare announced Thursday it has captured 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its entire Sonosite point-of-care ultrasound (POCUS) system to be used for lung and cardiac imaging with patients who have COVID-19 infection.

Simultaneously, the company announced it has released a comprehensive user guide that can help providers use their POCUS technology to more easily and accurately recognize findings associated with COVID-19 that are related to lung and cardiac conditions.

“POCUS has emerged as a critical tool to support clinicians in their tireless efforts to evaluate lung and cardiac complications to COVID-19,” said Diku Mandavia, M.D., FACEP, FRCPC, senior vice president and chief medical officer of Fujifilm Sonosite, Inc.

According to Vi Dinh, M.D., an emergency medicine and critical care physician at Loma Linda University Medical Center who has used the system, it can play a vital role in the timely delivery of care.

“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,” he said. “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 asses the disease severity to determine the optimal management plan for the patient.”

In particular, he said, POCUS is not only faster to use, but it is also safer and easier to sanitize during a pandemic.