Healthcare Industry News:  computed tomography 

Devices Radiology Gastroenterology FDA

 News Release - August 4, 2010

iCAD Announces FDA Clearance of the Company's Computer-Aided Detection Product for Virtual Colonoscopy

VeraLook CAD Now Commercially Available in the U.S.

NASHUA, N.H.--(HSMN NewsFeed)--(Nasdaq: ICAD ) The U.S. Food and Drug Administration has given clearance to VeraLook™, iCAD’s computer-aided detection product used in the interpretation of virtual colonoscopy exams. iCAD is an industry-leading provider of advanced image analysis solutions for the early detection of cancer.

“This breakthrough technology will aid radiologists in detecting and highlighting suspicious areas that could be missed during an initial review of a virtual colonoscopy exam,” said Dr. Abraham Dachman, Professor of Radiology and Director of Fellowship Programs at the University of Chicago. “As with breast and prostate cancer detection, computer-aided detection for virtual colonoscopy will help us find more cancers at an earlier stage.”

VeraLook from iCAD uses sophisticated interpretive technology to automatically identify polyps in images produced from a virtual colonoscopy, also known as CT colonography (CTC). A typical exam may contain between 1,200-1,500 images per patient. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.

Extensive testing by radiologists has demonstrated that the use of VeraLook improved reader sensitivity to all colonic polyps 6mm or larger in size in a statistically significant manner and particularly for smaller, more easily missed polyps and pre-cancerous polyps which can develop into malignancies over time. VeraLook has also demonstrated high standalone sensitivity to detecting polyps, while generating a low number of clinically acceptable false positive marks on CTC images. Reader and standalone testing was conducted using exams containing various types of polyps and on patients prepped using different methodologies.

“Since launching VeraLook in Europe last year, our technology has become an important tool in helping radiologists find colon cancers earlier and with greater confidence,” said Ken Ferry, President and CEO of iCAD. “It is estimated that more than 40 million individuals who are eligible for colon cancer screening do not undergo any screening at all. Virtual colonoscopy is a breakthrough technology that may prompt a greater number of people to have this potentially life-saving test.”

Approximately 51,000 Americans will die from colon cancer this year alone. According to the American Cancer Society, colorectal cancer is the second leading cause of cancer-related deaths in the United States. 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 may be linked to patients’ general discomfort with the traditional colonoscopy procedure.

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 and 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 screening CTC procedures is available in the U.S. from many private insurers and 22 states and the District of Columbia cover colon cancer screening per the American Cancer Society guidelines which includes virtual colonoscopy.

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 and computed radiography), Magnetic Resonance Imaging (MRI) and computed tomography (CT). Since receiving FDA approval for the Company’s first breast cancer detection product in 2002, more than 3,500 iCAD systems have been placed in healthcare practices worldwide. iCAD’s solutions aid in the early detection of the most prevalent cancers including breast and prostate, and in the future colon and lung cancer. For more information, call (877) iCADnow or visit www.icadmed.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995:

Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence, increased competition, customer concentration and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe”, “demonstrate”, “intend”, “expect”, “estimate”, “anticipate”, “likely”, and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release.


Source: iCAD

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