News | Interventional Radiology | July 08, 2021

Fujifilm’s Endosurgical Image Enhancement Technology for the ELUXEO Surgical System Receives FDA Clearance

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

Related Content

Avoiding contrast dyes for imaging tests not necessary if concerned about iodine allergy, peer-reviewed study concludes #MRI

Getty Images

News | Contrast Media Injectors | September 16, 2021
September 16, 2021 — FDB (First Databank), a leading provider of drug and medical device knowledge that helps healthc
This is an example of 3-D ultrasound imaging on a breast, designed to help increase efficiency and diagnostic accuracy in any practice. Image courtesy of Hologic.

This is an example of 3-D ultrasound imaging on a breast, designed to help increase efficiency and diagnostic accuracy in any practice. Image courtesy of Hologic.

Feature | Breast Imaging | September 15, 2021 | By Jennifer Meade
The...
Revised guidelines for lung cancer screening eligibility are perpetuating disparities for racial/ethnic minorities, according to a new study in Radiology.

Getty Images

News | Lung Imaging | September 15, 2021
September 15, 2021 — Revised guidelines for...
Revenues for teleradiology reading service providers are forecast to follow a similar profile over this period.

Outlook for 2021 and Beyond. As displayed in the figure below, these six market drivers are projected to result in teleradiology reading service volumes increasing by 21% in 2021 and nearly doubling by 2025. Revenues for teleradiology reading service providers are forecast to follow a similar profile over this period.

Feature | Teleradiology | September 15, 2021 | By Arun Gill
The closely tied relationship between...
To get more flexibility and cost savings from storage, healthcare organizations are increasing their investments in the cloud
Feature | Information Technology | September 15, 2021 | By Kumar Goswami
Healthcare organizations today are storing petabytes of medical imaging data — lab slides,...
Cloud services have been utilized within healthcare organizations for more than a decade. Now with the growth of artificial intelligence (AI) it is very common to see organizations adopting cloud services.

Getty Images

Feature | Information Technology | September 14, 2021 | By Jef Williams
Figure 1: MWT Schematic of a typical setup for detecting malignant tissues/tumors.

Figure 1: MWT Schematic of a typical setup for detecting malignant tissues/tumors.

Feature | Radiology Imaging | September 14, 2021 | By Brendon McHugh