Fuji gains 1st CR mammography clearance from FDA

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FUJIFILM Medical Systems USA announced Tuesday its digital mammography solution — Fuji Computed Radiography for Mammography (FCRm) — has gotten FDA clearance to be sold in the United States. This makes the device the first CR mammography system on the market and introduces a lower price point for facilities seeking an alternative to flat panel-based digital mammography.
 
Fuji’s Vice President, Marketing and Network Business Development Clay Larsen stated that the nod from the FDA “represents the first cost-effective full field digital mammography system based on CR technology to have passed the extraordinarily rigorous PMA process of the FDA. 

“Since the announcement that the ACRIN-DMIST found digital mammography to be more accurate than film screen mammography for a considerable percentage of women in the trial, more and more facilities have been actively seeking a digital mammography solution to best meet their needs,” added Larsen.

With the introduction of FCRm, Fuji is in the position to offer its own, total acquisition-to-archive system in combination with its Synapse PACS.  

The company highlighted a number of benefits of the FCRm system, including:

  • Image Quality.  FCRm provides 18 x 24 cm and 24 x 30 cm fields-of-view, 50-micron pixel sampling, and Fuji’s patented dual-side reading technology;

  • For a site that performs both general radiography and mammography exams, the FCR reader provides multi-purpose capability and the potential for subsequent cost saving;
  • Unlike other full-field digital mammography (FFDM) systems, Fuji’s FCRm does not require replacing the existing mammography acquisition unit. This has the potential to significantly lower conversion costs for facilities. Instead of a complete system overhaul, with FCRm the film cassettes are replaced with FCR cassettes. After the exam the digitally acquired information is sent to the facility’s PACS for interpretation.  

Fuji will be offering two configurations of its digital mammography reader – the multi-plate version that’s been available for general radiography since 2004, and the new single plate version. While the ClearView-CSm multi-plate reader can accommodate the volume of up to three screening mammography exam rooms, the ClearView-1m single-plate reader offers the option of being used right in an exam room, Fuji said.