Denver x-ray and mammography developer Fischer Imaging received an approvable letter from the FDA on its premarket approval (PMA) application for the SenoScan digital mammography system. The PMA was the result of the company's three-year, 1,500-patient study comparing its digital mammography product with conventional film mammography. Final approval to market the device is expected in coming weeks, pending final FDA review, according to the company.
By AuntMinnie.com staff writersJuly 23, 2001
Related Reading
Fischer shuffles sales, service operations, May 24, 2001
Fischer names Abboud to engineering post, May 10, 2001
EPMD to distribute Fischer fluoro units, May 9, 2001
Fischer revenues slip in first quarter, April 26, 2001
Fischer signs deal with Broadlane, March 23, 2001
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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)






