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Medicsight files 510(k) application with US FDA for ColonCAD

This article was originally published in Clinica

Executive Summary

Computer-aided detection (CAD) company Medicsight (London, UK) has submitted a 510(k) application to the US FDA for its ColonCAD software. The technology helps to identify early-stage colon cancer, using a CAD algorithm to analyse CT scans and automatically highlight suspicious areas. These include areas too small for the radiologist to see, or hidden behind folds in the colon. ColonCAD is already approved in Europe, Canada, Australia, China and Brazil. CT colonography, also known as "virtual colonscopy", was added to the American Cancer Society guidelines for colon cancer screening this year. As it is noninvasive, it could be used in those who do not wish to undergo colonoscopy.

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