Saneso’s 360-Degree Colonoscope Receives FDA Clearance

Saneso has been granted the FDA’s 510(k) clearance for its 360-degree field of view colonoscope.

Traditional colonoscopes are limited by a 140- to 170-degree field of view and can't see around the folds and turns of the GI tract, which “can cause them to miss 25 to 40 percent of polyps,” the company said.

To support its application, Saneso commissioned an independent study in which 324 U.S. endoscopists used the 360-degree colonoscope, comparing it to traditional single camera colonoscopes. Using 20 anatomic colon models, they all discovered more polyps with Saneso’s device versus traditional single-camera colonoscopes. Results of the study were published in the American Journal of Gastroenterology.