Computer-aided detection (CAD) developer Medicsight has filed a 510(k) application to the U.S Food and Drug Administration (FDA) for its ColonCAD image analysis software.
The London-based firm previously received regulatory approval to market ColonCAD in Europe, Canada, Australia, China, and Brazil.
Related Reading
Road to RSNA, CAD, Medicsight, October 30, 2008
Medicsight touts ESGAR colon CAD data, June 19, 2008
Medicsight parent trims net loss, March 18, 2008
Medicsight, Toshiba ink deal, February 14, 2008
Medicsight, Visage Imaging to collaborate, November 25, 2007
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![Axial images from unenhanced calcium score cardiac CT (left) and curved planar reformation images from CT angiography (right) show that higher long-term exposure to air pollution is associated with greater coronary artery calcium and more obstructive coronary artery disease (CAD). Top row: Images in a 68-year-old male patient with higher 10-year mean ambient air pollution exposure (7.9 μg/m3 for particulate matter measuring ≤2.5 μm in diameter [PM2.5] and 17.4 parts per billion [ppb] for NO2) with extensive CAD (coronary artery calcium score [CACS] >1,000 and obstructive CAD [≥70% diameter stenosis]). Bottom row: Images in a 57-year-old female patient with lower 10-year mean ambient air pollution exposure (6.3 μg/m3 for PM2.5 and 4.6 ppb for NO2) with no CAD (CACS = 0 and no obstructive stenosis).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/06/hanneman.r6SMLzkezo.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
