FDA OKs Olympus’ New Endoscopy System, Compatible Endoscopes

Olympus has achieved U.S. Food and Drug Administration (FDA) clearance for its new EVIS X1 endoscopy system and two compatible gastrointestinal (GI) endoscopes: the GF-1100 GI videoscope and CF-HQ1100DL/I colonovideoscope.
 
GIF-1100 is indicated for use in the upper digestive tract including the esophagus, stomach, and duodenum. CF-HQ1100DL/I is indicated for use in the lower digestive tract, including the anus, rectum, sigmoid colon, colon, and ileocecal valve.
 
“We are thrilled that we will soon be able to bring this new endoscopy system to physicians and their patients in the U.S.,” Richard Reynolds, president of the Medical Systems Group for Olympus America, told the press. “As a leading medical technology company, Olympus strives to offer physicians the most advanced technologies for minimally invasive procedures such as GI endoscopy.”
 
The EVIS X1 endoscopy system features new enhancements to help physicians to visualize GI bleeds and anatomical structures. These technologies are enabled by replacement of the Xenon bulb in EVIS EXERA III with five LEDs that can produce other light combinations, in addition to white light.
 
RDI (Red Dichromatic Imaging) offers optical-digital observation via red dichromatic narrow band light and green illumination light. TXI (Texture and Color Enhancement Imaging) emphasizes tonal changes, patterns, and image outlines—it can also correct brightness of dark areas. BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) maintains brightness of the bright part of the endoscopic image and corrects brightness of the image’s dark part.
 
NBI, RDI, TXI and BAI-MAC technologies aren’t intended to replace histopathological sampling as a means of diagnosis. According to the company, these are adjunctive tools for endoscopic examination that can be used to supplement Olympus white light imaging.