Guerbet has been granted breakthrough device status by the U.S. Food and Drug Administration (FDA) for the company's DUOnco Pancreas platform.
DUOnco Pancreas is a reading and analysis software designed to help radiologists detect focal lesions and dilation of the pancreatic duct on portal venous phase CT scans, which are signs of pancreatic cancer. It is meant to be used for adult patients undergoing contrast-enhanced pancreatic CT scans.
DUOnco Pancreas acts as a safety net for radiologists by reducing cognitive load and stress, Guerbet said.
Intrasense, a France-based company specializing in AI-enhanced medical imaging software, will be the legal manufacturer for the platform.
![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)
