iCAD’s Computer-Aided Detection Mammography System with Fuji’s Computed Radiography gets FDA Nod

| April 25, 2008

April 24th, 2008 by The MediNEWS Team

iCAD, Inc. has received the US Food and Drug Administration (FDA) marketing approval for its SecondLook® Digital, to be used in combination with Fujifilm Computed Radiography for Mammography (FCRm) systems.

In July 2006, Fujifilm got the approval for its FCRm from FDA, and since then, nearly 500 conventional analog examination rooms for mammography in US, were converted to digital. This advanced digital combination approach helps in detecting potentially malignant masses and calcifications, thereby assisting in the detection of unnoticed breast cancers.

The unique features of SecondLook Digital Computer-Aided Detection (CAD) mammography system include:

• Unique productivity to handle high case volumes
• Maximum sensitivity and optimal performance for improved patient care
• Seamless integration of patented algorithm of iCAD with existing systems from leading vendors like GE Healthcare, IMS Giotto, Hologic, Agfa Healthcare Direct Mammography Solutions and Siemens Medical Solutions, for improving the workflow
• Detects up to 72% of actionable missed cancers by an average of 15 months earlier than mammography alone
• Clearly marks the region suspected to be cancerous for exact reading without obscuring the view
• Generates CAD results to be viewed either on digital review stations or sent to a network printer
• Conforms with Digital Imaging and Communications in Medicine (DICOM) interface standards
• Enables clinical efficiency by priority queuing of studies
• Analyzes images in an average speed of up to 30 seconds.

Fuji FCRm system, a four-cassette slot Computed Radiography (CR) mammography reader, acquires images of the breast using imaging plates in combination with mammography x-ray machine. The image reader reads the images that are viewed either with an FDA approved display system or by using a film printer. FCRm is a solution offering high performance with a unique combination of image quality, versatility and practicality. With its capacity to perform both general x-ray and digital mammography, this system helps in the screening and diagnosis of breast cancer.

Breast cancer, in the United States, is the second most common cause for mortality in women with cancer, and according to the American Cancer Society, the estimated 2008 statistics show approximately 182,460 new cases and 40,480 deaths due to breast cancer in women. Mammography is a sensitive technique used for the early detection of breast cancer due to its ability to detect minute cancerous changes, 2 years prior to being noticed by visual or physical examination. However, the mammographic image is not clear around implants, and patients experience discomfort due to the compression of the breast tissue. According to the US National Cancer Institute, mammography is recommended every 1 to 2 years, in women from the age of 40 years onwards.

The combination of the computer-aided detection system and computer radiography helps in improving the existing mammography system for screening and diagnosing overlooked cancers, thereby increasing the level of patient care.

About iCAD, Inc. – Headquartered at Nashua, New Hampshire, iCAD is a leading Computer-Aided Detection solution provider for early detection and identification of cancer pathology. It provides high-performance systems for mammography markets (high, mid and low volume), and is being used for the detection of cancer in more than 2000 women healthcare centers worldwide.

About Fujifilm Medical Systems USA, Inc. – A subsidiary of Fujifilm Corporation, Tokyo, with headquarters at Stamford, Connecticut, Fujifilm Medical Systems USA provides diagnostic imaging products and network systems, which help in meeting the medical needs of the people worldwide. Digital x-ray, dry imagers, conventional x-ray equipment, women’s healthcare imaging and FCRm systems are some of the different imaging applications offered by Fujifilm.


1. Press Releases. iCAD receives FDA Approval for its SecondLook Digital for use with Fuji’s Digital Mammography System. iCAD Inc. Last accessed on 9 April, 2008.

2. SecondLook Digital. Digital CAD. iCAD Inc. Last accessed on 9 April, 2008.

Category: Digital Pathology News, Radiology

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