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Approval is for new system designed to improve visualization.
Fujifilm Medical Systems, USA, Inc., announced this week that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Oxygen Saturation Endoscopic Imaging System.
This system is designed to improve visualization for gastrointestinal, colorectal, and advanced endoscopy and surgical procedures.
By enabling the visualization of hemoglobin oxygen saturation (StO2) levels in real time with laparoscopic and/or endoscopic images, company official said, the system can help surgeons identify ischemic tissue. As a result, they could potentially prevent tissue necrosis.
“The prognosis is poor for tissue necrosis resulting from [gastrointestinal] procedural complications and the reduction in mortality relies on early detection and intervention,” says Taisuke Fujita, vice president of Fujifilm’s endoscopy division. “As long-standing leaders in endoscopic imaging, we’re thrilled to have evolved our image enhancement capabilities to address this deadly complication.”
This new system is an upgrade option to the ELUXEO® Surgical System. It will add StO2 visualization mode to the existing Blue Light Imaging, Linked Color Imaging®, and White Light Endoscopy modes. Implementing this new mode can give surgeons even more unique information for better diagnoses during procedures.
This 510(k) clearance comes on the heels of Fujifilm receiving FDA Breakthrough Device Designation six months ago for its endoscopy image enhancement technology.
According to company officials, the system will be available in the United States later this summer and globally later this year.