iCAD Submits Lung Cancer Detection Support Product to the FDA - Distribution Agreements in Place with TeraRecon and Viatronix - NASHUA, N.H., April 18 /PRNewswire-FirstCall/ -- iCAD(R), Inc. (NASDAQ: ICAD), an industry-leading provider of Computer-Aided Detection (CAD) solutions for the early identification of cancer, today announced that it recently submitted its Premarket Notification 510(k) Application with the U.S. Food and Drug Administration (FDA) seeking clearance to market and sell its first product for use in the detection of lung cancer. As an image processing application intended to support computed tomography (CT) review workstation software, iCAD's lung cancer detection product has been designed to make the medical review of lungs in CT scans more efficient and productive. The solution identifies roughly-spherical objects in the lung that meet radiologist-specified size, shape and brightness criteria, enabling healthcare professionals to improve workflow by spending more time reviewing potential areas of lung cancer concern. "Our recent lung cancer detection support product FDA submission marks an important milestone for iCAD," said Scott Parr, President and CEO of iCAD, Inc. "We look forward to helping the medical community improve CT Lung workflow productivity by using our imaging expertise and advanced technology to make medical services more effective, more accessible and more affordable for patients worldwide." Distribution agreements for iCAD's lung cancer detection products are already in place with TeraRecon, Inc. and Viatronix, Inc., both of which are expected to commence marketing of the offering as soon as FDA approval is received and product development and release plans are finalized. iCAD's submission was made to Underwriters Laboratories (UL), as a representative of the FDA under the FDA Accredited Persons Program, created by the FDA Modernization Act of 1997 (FDAMA). The purpose of the program is to improve the efficiency and timeliness of FDA's 510(k) process, the process by which most medical devices receive marketing clearance in the United States. Under the program, FDA has accredited third parties that are authorized to conduct the primary review. About iCAD, Inc. iCAD, Inc. is an industry-leading provider of Computer-Aided Detection (CAD) solutions that enable healthcare professionals to identify cancer and other life-threatening conditions earlier by making medical services more effective, more accessible and more affordable for patients worldwide. Recipient of Frost & Sullivan's Growth Strategy Leadership award and repeatedly recognized as offering "The Winning Combination" of Price and Performance by MD Buyline, iCAD offers a comprehensive range of high-performance, upgradeable CAD systems for the high, mid and low volume mammography markets. As the most frequently selected CAD solution for film-based and digital breast screening, iCAD is entrusted with the task of early cancer detection by almost one thousand women's healthcare centers worldwide. For more information, call +1 866 iCADnow or visit http://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 other 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. DATASOURCE: iCAD, Inc. CONTACT: For more information on iCAD, Inc., contact Kevin McGrath of Cameron Associates at +1-212-245-4577 or via email at Web site: http://www.icadmed.com/

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