Fujifilm Sonosite announced that it has received 510(k) clearance from the FDA for its entire point-of-care ultrasound (POCUS) portfolio for lung and cardiac imaging.
“POCUS has emerged as a critical tool to support clinicians in their tireless efforts to evaluate lung and cardiac complications of COVID-19,” said Dr. Diku Mandavia, chief medical officer of Fujifilm Sonosite, in a news release. “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.”
The Bothell, Wash.-based company also released a user guide on how healthcare providers can best use the newly cleared technology to 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,” said Dr. Vi Dinh, an emergency medicine and critical care physician at Loma Linda University Medical Center, in Loma Linda, Calif. “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 Fujifilm Sonosite president & COO Rich Fabian. “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.”