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FDA clears gastroscope offering wider field of view
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The FDA granted 510(k) clearance to EndoChoice for its Fuse gastroscope, which offers physicians an expanded 245-degree field of view, according to a news release.
“This clearance by the FDA is yet another milestone in our efforts to make the Fuse system available to more hospitals and clinics,” Mark Gilreath, founder and CEO at EndoChoice, said in the release.
The device employs a proprietary method of designing and manufacturing flexible circuits that allows for additional small cameras on the tip of the flexible endoscope. The Fuse gastroscope has two cameras while the Fuse colonoscope has three cameras.
The multiple cameras display images on high-definition screens arranged for a full-spectrum view and allow doctors greater ability to see into and behind the natural folds of the stomach and colon.
The gastroscope offers a 245-degree field of view, according to the release said, while traditional gastroscopes are limited to 140 degrees.
Studies have demonstrated the increased field of vision results in a statistically significant improvement in physicians’ ability to locate adenomas or precancerous lesions when compared with traditional single-view endoscopes, the release said.
“The data from the Full Spectrum Endoscopy Tandem study would indicate that Fuse is a radical improvement over the tools we’ve used in the past to fight GI disease,” Douglas K. Rex, MD, professor of medicine at Indiana University, said in the release.