FDA approves Carestream's PMA for mammo software

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The FDA has granted a premarket approval (PMA) supplement for screens and image processing software for Carestream Health’s CR mammography system.

The Rochester, N.Y.-based Carestream said its EHR-M3 screens are its third generation of screens designed for mammography, with higher DQE (detective quantum efficiency) on the new screens.

The optional Carestream DirectView CR Mammography feature allows users of the Classic, Elite, CR 850, CR 950 and CR Max systems to perform mammograms in addition to general radiography exams, the company said. These CR-based mammography systems are part of digital mammography technologies from Carestream, including mammography RIS/PACS; computer-aided detection for its CR systems; and output to DryView Laser Imaging Systems