Eastman Kodak Health Imaging has received a U.S. Food and Drug Administration approvable letter for its mammography computer-aided detection (CAD) device, according to the Rochester, NY-based vendor. An approvable letter is a precursor to receiving final FDA marketing approval on a new product providing that certain criteria, such as a good manufacturing practices (GMP) review, is met.
The company plans to offer CAD software as a stand-alone product and as a component of its digital capture and image-and-information management systems, Kodak said.
By AuntMinnie.com staff writersNovember 11, 2003
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Kodak medical sales edge up on global growth, October 23, 2003
Kodak to bring RIS to U.S., October 14, 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)






