Agfa HealthCare has received U.S. Food and Drug Administration (FDA) clearance for its DX-M digitizer with needle-based detectors.
In addition to the needle-based detectors, the computed radiography (CR) mammography package features Agfa's Musica2 image processing software and a five-cassette drop-and-go buffer to provide high throughput, according to the vendor. The reader unit can also be used with general radiography detectors, Agfa said.
DX-M is part of Agfa's digital mammography offering, which includes the company's Impax for Breast Imaging diagnostic workstation and DryStar imagers. The digitizer has also received European Reference Organization for Quality Assured Breast Screening and Diagnostic Services (EUREF) certification. It is available now in the U.S.









![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)






