FDA Grants 510(k) Clearance for Fujifilm’s New Endosurgical Image Enhancement Technology for the Company’s ELUXEO Surgical System
This FDA-designated Breakthrough Device is now cleared and is scheduled to commercialize late-summer
Lexington, Mass.- July 8, 2021 - FUJIFILM Medical Systems U.S.A., Inc.- a leading provider of endoscopic imaging and endosurgical solutions, today 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 StO2 levels 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,” says 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,” says 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.”
Fujifilm will showcase its ELUXEO Surgical System with this new image enhancement technology at the annual Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conference August 31 - September 3, 2021. Click here to learn more about Fujifilm’s solutions for endosurgery.
FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of unrivaled diagnostic imaging products and medical informatics solutions that meet the evolving needs of healthcare facilities today and into the future. Medical imaging solutions span digital radiography (DR), detectors, portables and suites, mammography systems with digital breast tomosynthesis, computed tomography solutions for oncology and radiology applications, as well as technologically advanced flexible and surgical endoscopy solutions. Fujifilm enables interoperability through its Systems Integration offering as well as its comprehensive, AI-supported Synapse® Enterprise Imaging portfolio, which includes the TeraMedica Division of Fujifilm. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Lexington, Massachusetts. For more information please visit www.healthcaresolutions-us.fujifilm.com.
FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, highly functional materials, document solutions and imaging products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2021, the company had global revenues of $21 billion, at an exchange rate of 106 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.