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.