Medicsight PLC (AIM: MDST), industry leader in the development of Computer-Aided Detection (CAD), today announces the submission of a 510(k) Premarket Notification to the United States Food and Drug Administration (FDA) for clearance to market its ColonCADTM image analysis software throughout the US. Submission of the 510(k) notification enters Medicsight into a FDA review process. Successful clearance of the product will enable the Company to access the world's largest healthcare market.

Medicsight has completed a large multi-reader CT Colonography 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.

The Company has already received regulatory approval from the necessary regulatory bodies to market ColonCADTM throughout Europe, Canada, Australia, China, and Brazil. Colon CAD technology represents a breakthrough in radiology, providing a tool which can assist radiologists in the detection of colonic lesions. If detected early, colon cancer is often treatable, making this technology attractive to both patients and healthcare systems alike.

"Medicsight have assembled a strong team of leading clinical, statistical, and regulatory experts to produce a 510(k) submission which we believe clearly demonstrates the safety and effectiveness of the ColonCAD product," said David Sumner, CEO of Medicsight

He continued "We are excited about seeking marketing clearance for the Medicsight ColonCAD product in the US at a time when we anticipate that the demand for CT colonography will rapidly increase. The recently reported outcomes of the US National CT Colonography Trial (ACRIN 6664) 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. Medicsight have established a large network of distribution partners ready to deliver the ColonCAD solution to end users once necessary regulatory clearances are in place. "

Disclaimer: Medicsight cannot predict when, or if, clearance will be gained.

Notes to editors
About Medicsight
Medicsight PLC is a UK-headquartered, research driven, leading developer of computer-aided detection (CAD) and image analysis software for the medical imaging market. The CAD software automatically highlights suspicious areas on computerised tomography (CT) scans of the colon and lung, helping radiologists to identify, measure and analyse potential disease and early indicators of disease. Medicsight's CAD software has been validated using one of the world's largest and most population diverse databases of verified patient CT scan data. Medicsight's ColonCAD^™ and LungCAD^™ software products are seamlessly integrated with the advanced 3D visualisation workstations of several industry-leading imaging equipment partners.

About Computer-Aided Detection
With increasingly sophisticated radiological imaging hardware such as Multi-Detector CT scanners, radiologists are facing a growing challenge in the amount of detailed patient image data that they must review for each patient examination. Some CT scan examinations generate as many as 2000 images per patient. Review of this data by the radiologist is not only time-consuming but also prone to error due to reader fatigue. CAD software can help the reviewing radiologist by analysing the image data and automatically highlighting suspicious regions of interest for closer inspection. Without CAD software some potential abnormalities or areas of disease may be overlooked. This can be critical for diagnosis and the management of patient outcomes as early detection of disease greatly increases the probability of successful treatment and a positive therapeutic outcome. In addition to supporting individual radiologists CAD also has the potential to help standardise CT interpretation across both individuals and institutions thereby supporting population based screening programmes.

About Medicsight's CAD software
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.

Both CAD products seamlessly integrate with the advanced 3D visualisation platforms of industry-leading imaging equipment partners. The integrated systems provide sophisticated image viewing capabilities, including 3D reconstructed image data, with the added advantage of demonstrating automatic CAD findings to assist clinical end users in the detection and analysis of disease. This allows clinical end users to perform either a 'second read', where CAD findings are displayed to the user after completion of an initial review of the CT scan data, or a 'concurrent read' where CAD findings are displayed during the user's initial review of the original CT scan images.

Since inception, Medicsight has developed close and lasting relationships with some of the world's foremost clinicians in product related areas. This provides the Company with a wealth of clinical expertise and dedicated clinical research to support ongoing product development. Medicsight also collaborates with a number of leading academic institutions and clinical research programmes worldwide to develop the Company's comprehensive database of population diverse verified patient CT scan data, thus allowing Medicsight's products to be validated to the highest possible standards