Carestream Health of Rochester, NY, has received approval from the U.S. Food and Drug Administration (FDA) for a premarket approval (PMA) supplement for advanced screens and image processing software for the company's computed radiography (CR) mammography system.
Carestream Health said the system has higher DQE (detective quantum efficiency) with the new EHR-M3 screens. This latest approval also covers the application of Carestream's advanced image processing algorithm, designed to enhance the overall display quality of mammography images, according to Carestream.
These features have been in use in other markets around the world since earlier this year; these latest approvals allow them to be implemented in clinics, breast imaging centers, and hospitals in the U.S., Carestream said.
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