ColonCAD Cleared by FDA
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.
Use of virtual colonoscopy is increasing in the US, despite question about payment.
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