iCAD, Inc. announced it has submitted data to the U.S. Food and Drug Administration (FDA) seeking 510(k) clearance of its VeraLook computer-aided detection (CAD) technology for CT colonography

iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis and workflow solutions for the early identification of cancer, announced it has submitted data to the U.S. Food and Drug Administration (FDA) seeking 510(k) clearance of its VeraLook computer-aided detection (CAD) technology for CT colonography (CTC), or “virtual” colonoscopy. CTC employs cutting-edge, advanced visualization technology to produce three-dimensional images that permit a thorough and minimally invasive evaluation of the entire colorectal structure. iCAD’s VeraLook product uses advanced algorithms to detect and highlight potential polyps warranting closer review by a radiologist.

VeraLook has the potential to reduce oversight errors that could occur during review of a virtual colonoscopy exam, due to the large number of images (approximately 1500) generated by the CT system. By incorporating CAD with virtual colonoscopy, radiologists can use an image analysis tool that detects and marks potential polyps in an effort to improve detection of pre-cancerous polyps. VeraLook technology is currently available in Europe.

More than 50,000 Americans will die from colon cancer this year alone. According to the American Cancer Society, colorectal cancer is second only to lung cancer as America’s leading cancer killer. When caught early, colon cancer is highly treatable but less than half of the Americans who are recommended to be screened for colon cancer are actually tested. This reluctance can be directly linked to patients’ general discomfort with the traditional colonoscopy process.

CTC is an accurate alternative to colonoscopy to detect polyps. Since it requires no sedation, patients undergoing a CTC exam are able to return to their normal activities immediately following the examination. Reimbursement for diagnostic CTC procedures is available in the U.S. from many private insurers and 26 states currently mandate that patients with private healthcare coverage are ensured access to virtual colonoscopy.

"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,” said Ken Ferry, president and CEO of iCAD. “Upon FDA clearance of our VeraLook product, we will further expand or portfolio of image analysis and workflow solutions to assist the radiologist in finding the most prevalent cancers earlier and with greater confidence.”

About iCAD, Inc.

iCAD, Inc. is an industry-leading provider of advanced image analysis and workflow solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing cancer earlier. iCAD offers a comprehensive range of high-performance, upgradeable Computer-Aided Detection (CAD) systems and workflow solutions for mammography (film-based, digital radiography (DR) and computed radiography (CR)), Magnetic Resonance Imaging (MRI), and Computed Tomography (CT). Since receiving FDA approval for the Company’s first breast cancer detection product in 2002, over 3,100 iCAD systems have been placed in healthcare practices worldwide. iCAD’s solutions aid in the early detection of the most prevalent cancers including breast, prostate and in the future, colon and lung cancer. For more information, call (877) iCADnow or visit www.icadmed.com.

Source: iCAD, Inc.

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