Lexington, Mass., September 26, 2019 – 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:
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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.”