Medicsight Seeks FDA 510(k) Clearance to Market its ColonCAD(TM) Software in the U.S.
Published: Nov 18, 2008
NEW YORK, Nov. 18 /PRNewswire-FirstCall/ -- Medicsight PLC, a subsidiary of MGT Capital Investments, Inc. , and an industry leader in the development of Computer-Aided Detection (CAD) and image analysis software, today 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."
About MGT Capital Investments, Inc.
MGT Capital Investments, Inc. is a technology holding company that focuses on investments in the global healthcare information technology market. The Company has two subsidiaries, Medicsight PLC and Medicexchange PLC.
Medicsight PLC (AIM: MDST) 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 computerized tomography (CT) scans of the colon and lung, helping radiologists to identify, measure and analyze 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(TM) and LungCAD(TM) software products are seamlessly integrated with the advanced 3D visualization workstations of several industry-leading imaging equipment partners.
Medicexchange PLC provides medical imaging professionals with a global web portal containing an online sales, jobs and information channel for diagnostic, treatment and surgery planning solutions. This combined with a variety of relevant clinical papers, training materials and content gives these professionals access to information and products that they otherwise would have difficulty accessing.
Additional information can be found at www.mgtci.com.
All forward-looking statements are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on current management expectations that involve risks and uncertainties that may result in such expectations not being realized. Potential risks and uncertainties include, but are not limited to, the risks described in company filings with the Securities and Exchange Commission.
CONTACT: Todd Fromer, +1-212-896-1215, firstname.lastname@example.org or Garth Russell,
+1-212-896-1250, email@example.com, both of KCSA Strategic Communications
for MGT Capital Investments, Inc.
Web site: http://www.mgtci.com/