News | Interventional Radiology | July 08, 2021

This FDA-designated Breakthrough Device is now cleared and is scheduled to commercialize late-summer

Fujifilm Medical Systems U.S.A., Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Fujifilm’s new image enhancement technology - the Oxygen Saturation Endoscopic Imaging System - which was developed to improve visualization during gastrointestinal, colorectal, and advanced endoscopy and surgical procedures.

July 8, 2021 — Fujifilm Medical Systems U.S.A., Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Fujifilm’s new image enhancement technology - the Oxygen Saturation Endoscopic Imaging System - which was developed to improve visualization during gastrointestinal, colorectal, and advanced endoscopy and surgical procedures. The new image enhancement technology enables real-time visualization of hemoglobin oxygen saturation (StO2) levels in tissue using laparoscopic and/or endoscopic imaging. Being able to detect StOlevels helps surgeons identify potentially ischemic tissue, better positioning them to prevent tissue necrosis.

“The prognosis is poor for tissue necrosis resulting from GI procedural complications and the reduction in mortality relies on early detection and intervention,” said Taisuke Fujita, Vice President, Endoscopy Division, FUJIFILM Medical Systems U.S.A., Inc. “As long-standing leaders in endoscopic imaging, we’re thrilled to have evolved our image enhancement capabilities to address this deadly complication.”

This 510(k) clearance comes six months after the FDA granted Fujifilm’s new image enhancement technology its “Breakthrough Device Designation,” which is reserved for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

This new technology is an upgrade to Fujifilm’s ELUXEO Surgical System. Soon, physicians will have a greater suite of image enhancement tools available to them at the touch of a button- the Blue Light Imaging (BLI), Linked Color Imaging (LCI), and White Light Endoscopy modes currently available with ELUXEO, as well the new StO2 visualization mode. Each image enhancement technology provides physicians with unique data allowing them to better diagnose issues while in procedures.

“Since receiving the FDA’s Breakthrough Device Designation we’ve been working to expedite the process of getting this critical technology into surgeons’ hands,” said Stephen Mariano, Vice President of Global Endosurgical Research and Development, FUJIFILM Medical Systems U.S.A., Inc. “We’re excited to commercialize this new technology in the United States later this summer, and plan to launch the technology globally shortly thereafter.”

For more information: www.fujifilmholdings.com

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