Fuji gets much-awaited FDA 'approvable letter' for CR mammography

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FUJIFILM Medical Systems USA on Tuesday announced it is "one step closer" to getting its computed radiography mammography (FCRm) system to market in the U.S., having just received an approvable letter from the FDA for what the company calls "the world’s leading full-field digital mammography system." Fuji said the letter indicates that the FDA has completed its review of Fuji’s Pre-Market Approval (PMA) application and that it is approvable. Once approved, the Fuji unit would be the first CR mammography system available for sale in the U.S.

“We are excited that the FDA has completed its review of our PMA application,” said Andy Vandergrift, Fuji’s national marketing manager, Women’s Healthcare Imaging. “Facilities worldwide are already benefiting from FCR m’s unique combination of image quality, flexibility, and practicality. We are pleased that we are one step closer to FDA approval so that facilities in the U.S. can implement this high performance, cost-effective solution.”

Unlike other digital mammography systems available today, Fuji’s CR mammography system does not require replacing the existing mammography acquisition unit. This significantly lowers conversion costs.  Additionally, the FCR m reader will provide multi-purpose capability for both mammography and general radiography exams, delivering significant cost savings for sites that perform both exams. 

The system will provide both an 18 x 24 cm and 24 x 30 cm field-of-view, 50-micron pixel sampling, and Fuji’s patented dual-side reading technology that results in "unprecedented levels of dose efficiency compared to traditional CR systems," according to Fuji.

The company said more information on the system, including price, will be available once final approval from the FDA is received. Fuji did say that the FCR m leads the global market in full-field digital mammography, with installations in more than 2,800 facilities in Europe, Asia, South America, the Middle East, Oceania and Africa. The system also was recently approved by Health Canada.