Medicsight Announces FDA Market Clearance For ColonCAR Software

Main Category: Radiology / Nuclear Medicine
Also Included In: MRI / PET / Ultrasound;  Medical Devices / Diagnostics
Article Date: 28 Nov 2006 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Medicsight PLC (Amex: MGT) announced today it has received FDA 510(K) clearance for Medicsight ColonCAR 1.2.1, an image analysis software tool designed to be used with CT colonography (virtual colonoscopy) to assist radiologists in searching for and measuring potential colorectal polyps. Medicsight introduced the product at the 92nd Scientific Assembly and Annual Meeting of the Radiological Society of North America conference this week at McCormick Place in Chicago.

Medicsight's ColonCAR (Computer Assisted Reader) uses a series of filters deployed against image data from CT colonography studies. The filters highlight spherical areas as small as 5mm (or the size of a small pea), allowing radiologists to examine these areas in 3D in order to judge their potential as true polyps.

Radiologists are also able to manually highlight any irregularities for closer inspection. Once suspected polyps are found, the software can determine the shape and features, precisely identifying the boundaries and showing the lesion in 3D with automatic diameter and volume measurements. This allows the radiologist to accurately review and monitor polyps over time.

"We are really excited about bringing this innovative and leading product to market and the benefits it will mean for radiologists," says Etienne Vanderstokker, CEO of Medicsight PLC. "We are confident that the integrated solution will create ideal workflow and optimize reading times for end user productivity, thereby giving Medicsight the opportunity to capitalize on the ever increasing customer demand for CAD."

Medicsight PLC will be present during RSNA, which is being held from November 26th through December 1st, 2006 at Chicago's McCormick Place, and will show their product at the South Building A, booth (#5544).

Colorectal cancer is the third most common cancer found in men and women in the U.S., according to the National Cancer Institute. American Cancer Society statistics on colon and rectal cancer estimated 148,610 new colorectal cases to be diagnosed in 2006, accounting for almost 14 percent of annual cancer deaths.

The Medicsight ColonCAR software will be integrated within leading imaging 3D advanced visualization products from TeraRecon Inc., Viatronics Inc. and Vital Images Inc. Medicsight announced FDA 510(k) clearance for ColonCAR last Thursday, November 23rd.

Medicsight's ColonCAR software will also be available for order through a new medical portal, Medicexchange.com, which is being launched this week at the RSNA show in Chicago.

About Medicsight

Medicsight is a pioneer in the development of enterprise-wide computer-aided detection (CAD) and Computer Assisted Reader (CAR) software used by the imaging community to aid in earlier detection of disease. Medicsight's unique software solutions have been validated using some of the world's largest and most population-diverse verified CT scan databases to help clinicians identify, measure, and analyze suspicious pathology of the lung and colon. The company's products include ColonCAD and ColonCAR, the first technology available for CT colonography, and LungCAD and LungCAR. These products allow users to perform a concurrent-read that allows clinicians to review the original image simultaneously with the Medicsight CAD findings, which results in improved workflow and productivity. Medicsight continues to develop CAD software for a variety of conditions that can help in the early detection of disease and ultimately improve patient outcomes.

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.

Medicsight, Inc.
http://www.medicsight.com/