July 12, 2006—FUJIFILM Medical Systems USA (Stamford, Conn) announced yesterday that it has received the long-awaited FDA approval for its digital mammography solution, the Fuji Computed Radiography for Mammography (FCRm), to be sold in the United States.

Fuji’s CR mammography system already is a widely used digital mammography technology around the world, and the company expects to see rapid adoption of the system in the United States. FCRm provides 18- x 24-cm and 24- x 30-cm fields of view, 50-micron pixel sampling, and dual-side reading technology for better dose efficiency; it also offers multi-purpose capability for sites offering both general radiography and mammography exams.

Because the system does not require facilities to replace their existing mammography acquisition unit—instead, the film cassettes are simply replaced with FCR cassettes, and the digitally acquired information is sent to the PACS—the conversion costs for facilities is lower. Both configurations—the ClearView-CSm (a multi-plate reader) and the ClearView-1m (a single-plate reader)—are expected to retail at about half the cost per room of currently available flat-panel digital mammography solutions.

“Mammography is clearly the best screening tool we have for the detection of breast cancer,” explained Gillian Newstead, MD, director of clinical breast imaging at the University of Chicago and one of the reading radiologists for Fuji’s FDA trial. “And with digital mammography proven to offer clear benefits, it’s important that the technology become available in as many facilities as possible. Fuji’s combination of high performance and cost-effectiveness should immediately help bring the benefits of digital to more women sooner.”

–Cat Vasko