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US FDA Grants 510 (k) Clearance For Avantis Medical Systems’ Third Eye Retroscope

Avantis Medical Systems, Inc. announced that US FDA has granted the 510(k) clearance for its Third Eye Retroscope (Third Eye), supporting the claim for increased detection of cancerous and pre-cancerous polyps in the colon. This is the first of such technology to receive FDA clearance to enhance polyp detection when used in conjunction with the gold standard in colonoscopy. Third Eye Retroscope is indicated for use with colonoscopy providing the physician with an additional view of the colon for diagnostic and detection purposes. When the Third Eye is deployed through the instrument channel of a standard colonoscope, it provides the physician with a retrograde view of the colon along with the forward (colonoscope) view. Operating as a "rear view mirror" the Third Eye helps visualize blind spots in the colon that may not be revealed with the colonoscope alone. In addition to overall improvement in polyp detection, the Third Eye has shown to be equally effective in detecting polyps on both the right-side and the left-side of the colon, when compared to the colonoscope alone.