Fujifilm Sonosite receives FDA clearance for COVID-19 use of its cardiac ultrasound systems


Fujifilm Sonosite has received 510(k) clearance from the US Food & Drug Administration (FDA) for the company’s point-of-care ultrasound portfolio to support healthcare providers in performing accurate cardiac and lung imaging in COVID-19 patients.

“point-of-care ultrasound 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, senior vice president and chief medical officer of FUJIFILM Sonosite. “We’re very pleased that Fujifilm Sonosite’s point-of-care ultrasound 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.”

Coinciding with the company’s newly cleared 510(k), Fujifilm Sonosite announced the release of a comprehensive user guide designed to assist healthcare professionals on how to best utilise point-of-care ultrasound technology to correctly interpret ultrasound images to recognise the most typical COVID-19 findings relating to cardiac and lung conditions.

“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, emergency medicine and critical care physician at Loma Linda University Medical Center, in Loma Linda, USA. “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.”


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