EndoChoice Nabs 510(k) for Its Fuse Colonoscopy System
6/12/2013 8:17:53 AM
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The FDA clears EndoChoice’s Fuse colonoscopy system which provides a wider range of view and may help docs catch more tumors during screening. EndoChoice got the FDA's green light for the Fuse endoscopy system, which the company says features numerous improvements over traditional endoscopy technology and will help docs catch more tumors.
The Alpharetta, Ga.-based colonoscopy device maker said its clinical trials demonstrated that Fuse only has a tumor "miss-rate" of 8%, compared with 42% with a traditional device. Fuse is equipped with 3 small cameras that provide a 330 degree view (nearly double the range of typical colonoscopy cameras), and the device fits the images together to create a panoramic view of the GI tract illuminated small LED lights, according to the company.
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