Fuji gains 1st CR mammography clearance from FDA
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:
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.