Siemens Medical Solutions of Malvern, PA, has filed a premarket approval (PMA) application with the Food and Drug Administration for its first full-field digital mammography (FFDM) system, Mammomat NovationDR.
The first NovationDR prototype unit is being used for an ongoing clinical study at the Iris Cantor Center for Breast Imaging at the University of California, Los Angeles. The study will compare the content and image quality of analog and digital images taken at the same level of radiation exposure, Siemens said.
NovationDR is based on Siemens’ Novation 3000 mammography system, but uses a 25 x 29-cm flat-panel digital detector based on amorphous selenium.
By AuntMinnie.com staff writersApril 7, 2003
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Siemens tapped for all-digital facility, March 21, 2003
Siemens integrates C-arm with ultrasound, March 4, 2003
Siemens installs prototype FFDM at UCLA, January 15, 2003
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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)






