ICAD Receives FDA Approval For Its SecondLook Digital For Use With Fuji's Digital Mammography System

Main Category: Breast Cancer
Also Included In: MRI / PET / Ultrasound;  Regulatory Affairs / Drug Approvals
Article Date: 05 Apr 2008 - 0:00 PDT

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iCAD(R), Inc. (Nasdaq: ICAD), an industry-leading provider of Computer-Aided Detection (CAD) solutions, announced that iCAD's SecondLook(R) Digital Computer-Aided Detection system for mammography received approval from the U.S. Food and Drug Administration for sale with Fujifilm Computed Radiography for Mammography (FCRm) systems. SecondLook Digital for FCRm is the first CAD product approved and available in the U.S. for use with computer radiography (CR).

"The addition of CAD functionality to CR digital mammography takes screening and diagnostic capabilities to an unprecedented level," said Rachel Brem, M.D., Director of Breast Imaging and Interventional Care at the George Washington University Hospital. "CAD improves upon existing mammography systems by providing an ability to find overlooked cancers, helping the radiologist find cancer earlier and ultimately improve the level of care for every patient."

"iCAD's SecondLook Digital system coupled with the Fuji CR Mammography system will improve our ability to detect potentially malignant calcifications and masses and we expect that it will increase our overall standard of care," said Jeffrey Mendel, M.D., Chairman of Radiology at Caritas St. Elizabeth's Medical Center in Boston, Massachusetts. "Additionally, seamless integration of iCAD's product with our PACS system will improve the efficiency of our reading and our overall digital workflow."

Since Fujifilm received FDA approval for FCRm in July 2006, the company has enjoyed record sales in the U.S. market, enabling the conversion to digital of nearly 500 mammography exam rooms. FCRm is the world's most widely used digital mammography technology with shipment of more than 4,400 systems worldwide.

"Fujifilm and iCAD are prepared for a fast market roll-out. We have seen steadily increasing interest in CAD from existing and new Fujifilm customers. Our support teams are cross-trained and will work closely to provide complete and timely installations for customers that choose the powerful combination of iCAD and Fuji FCRm solutions," said Ken Ferry, president and CEO of iCAD.

"Fujifilm is extremely pleased to work with iCAD to bring this combination of advanced digital technology to market," said Andy Vandergrift, Fujifilm's National Marketing Manager, Women's Healthcare Imaging. "Fujifilm has already realized great success with FCRm and has the most complete acquisition-to-archive solution for digital mammography, including our Synapse(R) PACS. This combined offering with iCAD -- that is fully compatible with Synapse -- will enhance our product offering even further, broadening its appeal to even more facilities."

About iCAD, Inc.

iCAD, Inc. is an industry-leading provider of Computer-Aided Detection (CAD) 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 CAD systems for the high, mid and low volume mammography markets. iCAD is entrusted with the task of early cancer detection by more than 2000 women's healthcare centers worldwide.

About FUJIFILM Medical Systems USA, Inc.

As one of the FUJIFILM Corporation family of companies with 70 years of imaging experience and almost $25 billion in sales, FUJIFILM Medical Systems USA Inc. is a leading provider of diagnostic imaging products and network systems to meet the needs of healthcare facilities today and well into the future. Fujifilm's family of Imaging Systems products and technologies -- including digital x-ray, women's healthcare imaging, dry imagers, and conventional x-ray film and equipment -- are tailored to suit many different applications for a variety of imaging environments. Fuji Computed Radiography for Mammography (FCRm) has long been the world's most widely used Full Field Digital Mammography (FFDM) solution, and is already making a notable impact on the FFDM market in the United States since receiving FDA approval. FUJIFILM Medical Systems USA is headquartered in Stamford, CT. More information is available at http://www.fujimed.com.

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iCAD, Inc.
http://www.icadmed.com