FDA Approves iCAD SecondLook with Fuji FCRm

April 4, 2008 (Fuji News)

iCAD’s SecondLook® 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).

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 US 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.

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