FDA Grants Guerbet's Pancreatic Cancer Software Breakthrough Device Status

The U.S. Food and Drug Administration (FDA) has granted "Breakthrough Device" designation to DUOnco™ Pancreas, a software developed by Guerbet for the early detection of pancreatic lesions. Intrasense will serve as the legal manufacturer for the AI-enhanced medical imaging solution.

DUOnco™ Pancreas is designed to assist radiologists in identifying signs of pancreatic cancer, such as focal lesions and pancreatic duct dilation, on CT scans performed in the portal venous phase. The software is intended for adult patients undergoing contrast-enhanced CT scans of the pancreas.

The technology facilitates the "opportunistic detection" of pancreatic cancer by analyzing CT scans initially acquired for various clinical reasons. This approach could lead to earlier identification of patients with asymptomatic, early-stage pancreatic cancer, potentially increasing the number of candidates for surgical intervention. Guerbet states the software acts as a safety net for radiologists, reducing cognitive load and enhancing diagnostic confidence without replacing their expertise.

Pancreatic cancer is a highly lethal disease in the United States with a poor prognosis, where surgery remains the only potential cure. Current limitations in early detection mean fewer than 20% of patients are eligible for surgery at diagnosis. The FDA's Breakthrough Device designation aims to expedite the development and evaluation of DUOnco™ Pancreas, with the goal of improving patient outcomes and survival rates through earlier intervention.