Medicsight PLC has announced the submission of a 510(k) Premarket Notification to the United States Food and Drug Administration (FDA) for clearance to market its ColonCAD(TM) image analysis software throughout the U.S.
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 clinical 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 ColonCAD(TM) 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 Medicsight's Colon CAD technology attractive to both patients and healthcare systems alike.
"Medicsight has 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.
Mr. Sumner continued, "The recently reported outcomes of the U.S. 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 support the predicted growth of the U.S. CT Colonography market. With such promising market data forecasting growing demand for CT Colonography, our submission for marketing clearance for the Medicsight ColonCAD(TM) product in the U.S. is especially timely."