Eastman Kodak Health Group of Rochester, NY, has filed an application with Health Canada for regulatory clearance of its computed radiography (CR) system for mammography.
The filings are part of Kodak's plan to obtain approval in Canada for its Kodak DirectView CR mammography feature for its CR 850/950/975 systems.
Kodak already has submitted the final module of a premarket approval (PMA) to the U.S. Food and Drug Administration for approval of its CR system for mammography. Clinical trials were conducted at several sites in the U.S. and Canada.
Kodak currently is selling its CR mammography product in Europe, Asia, Japan, and Latin America.
By AuntMinnie.com staff writers
December 19, 2006
Related Reading
Kodak raises film prices, December 18, 2006
Kodak outfits U.S. Olympic training center, December 7, 2006
Kodak launches new DR unit, shows work-in-progress CR mammo, November 28, 2006
Kodak to collaborate with NDMA on European mammo screening, November 26, 2006
Kodak starts Tuscan PACS contract, November 20, 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)






