MedicSight ColonCAD 510(k) submission
This article was originally published in The Gray Sheet
Executive Summary
Medicsight submits 510(k) application Nov. 18 for image analysis software designed to aid radiologists in identifying pre-cancerous polyps and other disease markers in computed tomography colonography scans. Medicsight anticipates FDA clearance by March. The 510(k) is supported by the results of an American College of Radiology Network trial showing that CT colonography detects 90% of colon polyps detected by optical colonoscopy (1"The Gray Sheet" Sept. 22, 2008, p. 21)
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