Medicsight
Medicsight seeks FDA clearance to market colonography software in the US
Medicsight PLC, developer of Computer-Aided Detection software (CAD), is seeking clearance from the US Food and Drug Administration to market its colonography product throughout the country.
In a statement, the company said it submitted Premarket Notification to the FDA for clearance to market of its ColonCAD image analysis software, a move that will prompt a FDA review process.
Medicsight has completed a large multi-reader CT colonography trial involving the review of several hundred patient datasets to support the submission.
The company has already received regulatory approvals to market ColonCAD throughout Europe, Canada, Australia, China, and Brazil.
The outcomes of the US National CT Colonography Trial demonstrating the efficacy of CT colonography as a primary screening examination for colorectal cancer, and the inclusion of CT colonography in the 2008 American Cancer Society guidelines for colorectal cancer screening, increasingly supports the predicted growth of the US CT colonography market, the company said.
Medicsight added it cannot predict when, or if, clearance will be gained.
Medicsight's ColonCAD and LungCAD software use an advanced CAD algorithm to analyse CT scans of the colon and lung and automatically highlight suspicious areas that may be indicators of disease. CAD may highlight areas easily overlooked by the reviewing radiologist, such as small lesions or regions that are hidden from view behind folds in the colon or normal structures and surrounding tissue in the lung.
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