Medicsight now has FDA 510(k) clearance to market ColonCAD, a computer-aided detection system to aid in CT colonography.
Medicsight now has FDA 510(k) clearance to market ColonCAD, a computer-aided detection system to aid in CT colonography.
The system uses an algorithm to review data and highlight potential polyps in virtual colonoscopies.
The FDA decision was supported by a clinical trial in which 15 radiologists reviewed 112 CT colonography cases assisted and unassisted by ColonCAD. Reviews using the system showed greater accuracy.
