Medicsight Seeks 510(k) Clearance for ColonCAD

November 18, 2008 - Medicsight PLC has submitted for a 510(k) Premarket Notification to the FDA for clearance to market its ColonCAD image analysis software throughout the U.S.

Colon CAD can assist radiologists in the detection of colonic lesions. Medicsight has completed a large multireader CT Colonography clinical trial involving the review of several hundred patient datasets to support the FDA submission. This study was led by Professor Steve Halligan of University College Hospital, London, and demonstrates the significant benefits of ColonCAD technology on radiologists’ diagnostic performance.

Medicsight has already received regulatory approval from to market ColonCAD throughout Europe, Canada, Australia, China and Brazil.

For more information: www.mgtci.com