Fuji Photo Film Co., Ltd. (President and CEO: Shigetaka Komori) received Pre-Market Approval (PMA) on July 10, 2006 from the U.S. Food and Drug Administration (FDA)*1 for FCR PROFECT CS (Product name in the U.S.: FCRm), Fujifilm's Computed Radiography (FCR) mammography system, effective for early detection of breast cancer. PMA*2 is a type of FDA approval for clinical use of highly-innovative and advanced medical equipment prior to market distribution, granted upon FDA review of its clinical data and manufacturing / design information.
This is the world's first*3 PMA approval extended to a Computed Radiography (CR) system for mammography. The approval has also made Fujifilm the first Japanese company*4 to receive PMA approval in the area of radiology devices. In the United States, where the mammography screening system is well established, PMA approval is mandatory for digital mammography systems, as their diagnostic performance determines early cancer detection and affects the survival rate of patients. With the latest approval, Fujifilm can now start marketing the FCR system for mammography in the United States ahead of other CR manufacturers.
The FCR system for mammography uses Fujifilm's proprietary “DUAL Side Reading”*5 technology, high-resolution “50-micron pixel sampling”*6 and unique image-processing technology to obtain high-quality images, suitable for mammography to facilitate early detection of breast cancer. In addition to the advanced image quality, since the system is also capable of processing X-ray images for other parts of the body, users can continue using conventional film-based X-ray equipment instead of replacing it. With the versatility and practicality, around 3,000 units of the system have already been introduced at facilities worldwide, mainly in Japan and Europe, making it the world's most widely-used digital mammography system. We are committed to further expanding the use of digital mammography in the United States.
Fujifilm will continue to contribute to maintaining and promoting human health through developing FCR mammography systems and other leading-edge products, and supporting the Pink Ribbon campaign in Japan*7, which appeals the importance of early detection, early diagnosis and early treatment for breast cancer.
*1 FDA (Food and Drug Administration of the United States) is a U.S. government agency that governs medical and pharmaceutical products, and is part of DHHS (Department of Health and Human Services). *2 PMA (Pre-Market Approval) is a type of approval procedure required for highly-innovative and advanced medical equipment. Marketing of medical equipment requires a 510(k) (Pre-Market Notification) application for proving that the device is equivalent to a device already placed into one of the FDA classification categories, or a PMA application that involves even stricter screening. *3 As of July 10, 2006 *4 As of July 10, 2006, regarding radiological devices such as CT and MRI, defined by FDA *5 Fujifilm's proprietary image acquisition technology that absorbs X-rays at high efficiency for maximum use as signals. *6 The technology samples images at twice the conventional resolution at 20 pixels/mm to enable description of detailed and fine shapes. *7 In support of the Pink Ribbon campaign, Fuji Photo Film Co., Ltd. and Fujifilm Medical Co., Ltd. have served since 2003 as special sponsors for “Pink Ribbon Smile Walk”, the main event of the “Pink Ribbon Festival” in Japan.
Details of the PMA-approved equipment
1. Product name: FCRm “Scanner: ClearView-CSm(Japanese product name: FCR PROFECT CS)” ”IP:HR-BD(18x24cm)(24x30cm)” “IP Cassette Type DM(18x24cm)(24x30cm)” “Controller: Flash Plus IIPm and other options (Japanese product name: CR Console Plus)”
2. Date of FDA approval: July 10, 2006
3. Main features (1)Fujifilm's proprietary high-resolution image scanning technologies for mammography applications The use of Fujifilm's proprietary high-quality scanning technologies, including “DUAL Side Reading” and “50-micron pixel sampling”, has enabled high-speed scanning (approx. 80 images per hour at 18x24cm) of high-resolution images. The technologies are combined with the image processing application “Image Intelligence™”, installed in the FCR image / data control station “CR Console”, to achieve advanced image quality in mammography. (2) Versatility The system may be used as a scanning device for both general X-rays and mammography. (3) Practicality FCR can be combined with a conventional film-based imaging device to perform digital X-ray. FCR delivers digital mammography functionality at a low capital investment, unlike FPD (Flat Panel Detector) digital mammography devices, which requires replacement of the entire mammography setup including the imaging device. A single FCR unit can also cater to multiple X-ray rooms.