Fujifilm Sonosite Receives FDA COVID-19 510(k) Clearance for the Company’s Entire POCUS Portfolio

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September 3, 2020

Fujifilm Sonosite has announced they have received U.S. Food and Drug Administration COVID-19 510(k) clearance for the company’s entire POCUS portfolio.

Fujifilm Sonosite creates point-of-care ultrasound systems and medical informatics solutions along with transducers and accessories that can help physicians improve time-to-diagnosis, patient outcomes, procedural efficiency, and workflow.

“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.”

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 utilize POCUS technology to correctly interpret ultrasound images to recognize the most typical COVID-19 findings relating to lung and cardiac 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,” says 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.”

“Fujifilm Sonosite has long demonstrated its commitment to educating clinicians such as emergency physicians and ICU physicians who typically use POCUS to do bedside imaging,” said Rich Fabian, President and Chief Operating Officer of FUJIFILM Sonosite, Inc. “However, this pandemic calls for support from all medical professionals. So many diverse specialists are being asked to get in the trenches and help save lives in the COVID-19 battle. So now, with such widespread use of POCUS by so many types of clinicians, education is more important than ever and Sonosite is here to help.”

 

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