Planmed of Roselle, IL, has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its Planmed Nuance full-field digital mammography (FFDM) system.
Planmed Nuance is based on amorphous selenium detector technology and will come in two detector configurations: a 17 x 23.9-cm bucky and an optional 23.9 x 30.5-cm bucky. The unit also will feature the company's MaxView breast-positioning device, designed to enable radiologists to view more chest wall tissue on imaging exams.
Planmed anticipates PMA approval before the end of this year.
By AuntMinnie.com staff writers
June 30, 2006
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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)






