EndoChoice, a US-based medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Fuse gastroscope, which has two cameras and has a 245 degrees field of view.
The new gastroscope joins the company’s endoscopy system line of products that have been released earlier 2012 under the Fuse brand.
Physicians can see nearly twice as much surface area with the new fuse system when compared to traditional endoscopes.
The Fuse system also allows clinicians to see into and behind the folds that occur naturally in the colon and stomach anatomy.
The images of the anatomy are displayed on high-definition screens.
Recently, data supporting the Fuse system has been presented at the American College of Gastroenterology Annual Scientific Session in San Diego, California, and at the Union European Gastroenterology Week in Berlin, Germany.
When compared to traditional single-view endoscopes, the new device demonstrated greater ability in finding adenomas or precancerous lesions by researchers.
EndoChoice founder and CEO Mark Gilreath noted the company is 100% focused on serving the gastrointestinal professionals so they can give the best possible care to their patients.
"This clearance by the FDA is yet another milestone in our efforts to make the Fuse system available to more hospitals and clinics," Gilreath added.