FDA Response to iCAD’s 510(K) Anticipated (Nasdaq:ICAD)

iCAD, Inc. (Nasdaq:ICAD) discovers, develops and then brings into market “advanced image analysis and workflow solutions” that allow cancer to be detected in the initial stages. On May 26, 2009, the company disclosed to its stockholders that it has submitted a 510(K) application to the United States of America’s Food and Drug Administration (FDA). The application was submitted to get the regulator’s approval to use VeraLook™ computer-aided detection (CAD) technology in CT colonography (CTC) – which is also known as “virtual” colonoscopy. The company hopes to get the FDA’s response around February 26, 2010.

Even without the VeraLook™ CAD technology, the CTC is capable of taking and recording highly sophisticated three dimensional images of the colorectal structure from all directions. This allows physicians or radiologists to have a detailed and comprehensive study of the colorectal structure. However, the inclusion of the VeraLook™ CAD technology can improve the efficacy of the CTC by utilizing highly developed “algorithms” that would allow the spotting out of “potential polyps” which are of concern to the radiologists.

VeraLook CAD technology can also minimize the errors that usually happen when radiologists are analyzing the images obtained from a virtual colonoscopy exam. The errors are common because the CTC produces a lot of images (at least 1500) – all of which need to be analyzed for detecting potential polyps. However, the CAD technology can make the radiologists work easier and error free by utilizing an “image analysis tool” that would identify the polyps – which show the presence of cancerous cells.

Although VeraLook technology has been extensively used in Europe for several years, it is yet to be commercialized in the US, where approximately 50,000 people die every year due to colon cancer.

Ken Ferry, who is the Chief Executive Officer and also the President of iCAD, said:

“It is estimated that more than 40 million individuals who are eligible for screening do not undergo any screening at all. Virtual colonoscopy is a breakthrough technology that can make this potentially life-saving test accessible to a greater number of people. Upon FDA clearance of our VeraLook product, we will further expand our portfolio of image analysis and workflow solutions to assist the radiologist in finding the most prevalent cancers earlier and with greater confidence.”