FUJIFILM RECEIVES FDA CLEARANCE FOR SIX NEW ENDOSCOPIC IMAGING SOLUTIONS
Company expands interventional and core GI endoscopy portfolio
September 26, 2019
Lexington, Mass. – FUJIFILM Medical Systems, U.S.A., Inc., today announced the U.S. Food and Drug Administration (FDA) has issued 510(K) clearance for six (6) new endoscopes to be added to Fujifilm’s portfolio of endoscopic imaging solutions. These new endoscopes strengthen the company’s offering in core GI and interventional endoscopy.
“Receiving FDA clearance for six endoscopes is an important milestone for Fujifilm. As a company with many “firsts” in the endoscopy space, our goal is to always stay a step ahead, anticipate clinician needs and continue to advance the field,” says Taisuke Fujita, General Manager of FUJIFILM Medical Systems U.S.A., Inc. “Physicians perform more than 51 million gastrointestinal endoscopic procedures annually, and Fujifilm’s latest innovations are engineered to support them during even the most sophisticated procedures and interventions to ultimately enhance patient care.”
The following Fujifilm products have received FDA clearance:
ED-580XT Duodenoscope— The ED-580XT Duodenoscope features a removable single use distal end cap which provides access to the elevator for manual cleaning. The ED-580XT Duodenoscope combines optimal visual orientation with exceptional maneuverability and control, helping to achieve cannulation efficiently while keeping the focus on diagnosis and therapy even in the most challenging Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. The new design incorporates a smooth working channel and guidewire lock delivering efficient device advancement and exchange.
Fujifilm recently concluded its ED-580XT limited market evaluation (LME). In clinical use at multiple facilities, the ED-580XT received positive feedback from physicians who complimented the scope’s image quality, ease of advancements of large diameter devices, and performance and impressive wire locking mechanism.
Jack Brandabur, M.D., Medical Director and Co-Chair at Swedish Digestive Health Institute, and Executive Medical Director at Providence St. Joseph Health Digestive Health Institute, was one of the first to use the ED-580XT in clinical cases during Fujifilm’s LME, and has experience using a variety of Fujifilm’s endoscopic technologies.
“The ED-580XT guide wire-locking mechanism’s ability to hold multiple guide wires securely in place throughout procedures helped me work through my case load more efficiently, and the scope’s elevator mechanism delivered a high response rate, exceeding my expectations,” says Dr. Brandabur. “The Fujifilm team’s attention to detail, follow-through, accountability, and product knowledge are unsurpassed, and in my opinion, Fujifilm now has best-in-class endoscopic technology.”
Fujifilm received 510(K) clearance for the ED-580XT in the spring, and the product is now commercially available.
EI-580BT Short Double Balloon Endoscope - Fujifilm pioneered double-balloon endoscopy which enabled access to tortuous anatomy such as the intestine. With the addition of the EI-580BT Short Double Balloon Endoscope, Fujifilm adds to its portfolio with a Double Balloon endoscope that has a working length of 155 cm and working channel diameter of 3.2 mm, allowing access in altered anatomy and also accommodates the use of standard devices, while maintaining an instrument channel length and diameter that accommodates the use of standard devices. Fujifilm expects the EI-580BT to be commercially available in fall 2019.
EC-760P and EC-760S Colonoscopes, EG-760CT and EG-740N Gastroscopes — Fujifilm has added these four new 700 Series endoscopes to its Core GI portfolio. Now, the 700 Series portfolio is fully equipped with Ultra-Slim, Standard, Zoom, and Therapeutic gastroscopes and Slim, Adult, Standard and Zoom colonoscopes. The 700 Series scopes offer a unique combination of visualization, access, comfort, and control that together create an unparalleled experience in the endoscopy suite. Designed for use with the company’s ELUXEO® endoscopic imaging platform, Fujifilm’s 700 Series endoscopes are compatible with Linked Color Imaging (LCI®) and Blue Light Imaging (BLI) and are engineered to enable physicians to achieve advanced visualization in image-enhanced endoscopy. Fujifilm expects these 4 new scopes to be commercially available by November, 2019.
“The six recent FDA clearances on Fujifilm’s core GI and interventional endoscopes rounds out our portfolio, enabling us to serve the growing demands of hospitals across the US,” says Jason Heim, Vice President, Sales, FUJIFILM Medical Systems U.S.A., Inc. “Built upon our legacy of high-performance healthcare innovations and a more comprehensive portfolio than ever before, Fujifilm is well positioned to meet the demands of today’s busy health care systems. Our scope of solutions has never been stronger.”
FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of diagnostic imaging products and medical informatics solutions that meet the evolving needs of healthcare facilities both today and tomorrow. From an unrivaled selection of digital X-ray systems (DR: detectors, mobiles, and rooms), to the comprehensive Synapse® Enterprise Imaging portfolio, to full-field digital mammography systems with digital breast tomosynthesis, and computed tomography solutions, Fujifilm has products that are ideal for any size imaging environment. FUJIFILM Medical Systems U.S.A., Inc. – Endoscopy supplies high quality, technologically advanced endoscopic imaging solutions and devices to the medical field. Fujifilm’s TeraMedica Division, the leading provider of vendor neutral, enterprise-wide solutions for unrestricted medical image management and the core to the Synapse Enterprise Imaging portfolio, enables improved interoperability by connecting imaging content across the entire care continuum. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Lexington, Massachusetts. For more information please visit www.fujimed.com and www.fujifilmendoscopy.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, 2019, the company had global revenues of $22 billion, at an exchange rate of 111 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.
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