Cedara Software has received Food and Drug Administration 510(k) marketing clearance for I-ReadMammo, a new mammography reading workstation for diagnosis and screening.
The FDA clearance allows the Mississauga, Ontario-based firm to sell I-ReadMammo in the U.S. The workstation is capable of reading images from full-field digital mammography (FFDM) products from multiple vendors, Cedara said. In addition, the product can display traditional x-ray, ultrasound, and MRI images, the company said.
By AuntMinnie.com staff writersMay 19, 2004
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Cedara partners with Siemens, March 3, 2004
Cedara posts Q2 gains, February 10, 2004
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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)






