Women's healthcare vendor Hologic of Bedford, MA, has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the Selenia Dimensions 3D digital mammography tomosynthesis system.
Final approval of the company's premarket approval (PMA) application for the system is subject to satisfactory review and inspection of Hologic's manufacturing facility, methods, and controls.
The Selenia Dimensions 3D digital mammography system features breast tomosynthesis, which produces 3D images to reveal the inner architecture of the breast without distortion caused by tissue shadowing or density.
The system is available commercially in more than a dozen countries outside the U.S., including countries in Europe, Latin America, and Asia. Systems also are installed in Canada and Mexico.
Related Reading
Hologic posts mixed results for FY 2010, November 9, 2010
Hologic reports 5-year MammoSite results, November 2, 2010
FDA panel gives nod to Hologic tomosynthesis PMA, September 24, 2010
FDA panel to review Hologic tomo unit, September 23, 2010
Hologic completes Sentinelle acquisition, August 6, 2010
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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=100&q=70&w=100)
![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&dpr=2&fit=crop&h=167&q=70&w=250)
