Fujifilm Earns FDA “Breakthrough Device” Designation for Endosurgical Image Enhancement Technology
Company announces development of new image processing technologies designed to enhance visualization during therapeutic procedures
December 7, 2020
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Lexington, MA – FUJIFILM Medical Systems U.S.A., Inc.- a leading provider of endoscopic imaging solutions, today announced that the U.S. Food and Drug Administration (FDA) granted its Breakthrough Device Designation— reserved for medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions— for Fujifilm’s new, in-development, endoscopic light and image processing technology. Although not yet 510(k) cleared, the goal of Fujifilm’s in-development image processing technology is to arm surgeons with the resources needed to care for patients at risk for ischemic states of the gastrointestinal tract.
“Leveraging our 80+ year imaging legacy, we develop technologies designed to enhance visualization and guide healthcare providers as they make critical clinical decisions caring for their patients,” says Taisuke Fujita, General Manager- Endoscopy, FUJIFILM Medical Systems U.S.A., Inc. “We’re proud to receive this designation through the FDA’s Breakthrough Devices Program on the heels of several advancements in 2019, and we look forward to bringing more innovations to the endoscopic and endosurgical markets in the years to come.”
Fujifilm’s new image processing technology is being developed to enhance endosurgical visualization and will be an upgrade to the ELUXEO Surgical System-the company’s in-market video imaging system which leverages 4-LED multi-light technology to enable advanced visualization modes including White Light Endoscopy, Linked Color Imaging (LCI), and Blue Light Imaging (BLI). These imaging modes are designed to improve visualization, detection, and characterization during procedures.
In gastrointestinal procedures such as colorectal surgeries, anastomosis is performed following resections, sometimes resulting in a serious complication—anastomotic leaks. One of the major causes of anastomotic leaks is necrosis of ischemic tissue where the anastomosis is performed, and Fujifilm’s new technology is designed to assist physicians in identifying ischemic areas of tissue.
Anastomotic leaks can result in septic complications, and are shown to have a 10% higher mortality rate as compared to patients who did not develop anastomotic leaks (14% vs. 4%). In a Medicare data analysis of more than 200,000 patients who underwent colorectal surgery between January 1, 2013 and August 31, 2015, care admission costs for patients with anastomotic leaks were reported more than $30,500 greater and the length of stay was 12 days longer as compared to those without. The commercial analysis of both the bariatric and colorectal populations trended similarly to the Medicare population in regards to all outcomes measured. These staggering statistics have led industry to research and develop technologies to prevent and/or reduce anastomotic leaks.
“For decades Fujifilm has invested in the research and development of technologies to improve patient outcomes and reduce healthcare costs, and in recent years, we’ve elevated our focus in endosurgery,” says Stephen Mariano, Vice President of Global Endosurgical R&D, FUJIFILM Medical Systems U.S.A., Inc. “We look forward to working with the FDA as we prioritize the development and access of some of our exciting endosurgical innovations.”
Click here to learn more about Fujifilm’s solutions for endosurgery.
FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of innovative diagnostic imaging products and medical informatics solutions that meet and exceed the evolving needs of healthcare facilities today and into the future. It’s ever expanding 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, technologically advanced flexible and surgical endoscopy and fluoroscopy 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’s in vitro diagnostics (IVD) portfolio includes clinical lab reagents, and biomarkers to assess the risk for the development of hepatocellular carcinoma in patients with chronic liver disease. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Lexington, Massachusetts. For more information please visit www.fujifilmhealthcare.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, graphic systems, highly functional materials, optical devices, digital imaging and document 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, 2020, the company had global revenues of $22.1 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.