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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Carestream completes French install, November 12, 2010
FDA approves Carestream CR FFDM system, November 4, 2010
Carestream scores DRX retrofit sales, November 3, 2010
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![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&fit=crop&h=112&q=70&w=112)





