Guerbet secures Japanese PMDA certification for AI pancreas software
Guerbet announced its DUOnco™ Pancreas AI software has received certification from Japan's PMDA. The software assists radiologists in analyzing contrast-enhanced CT scans of the pancreas.
Guerbet, a global leader in medical imaging, has announced that its DUOnco™ Pancreas artificial intelligence software has received certification from Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This certification allows the software to be used in Japan to support the reading of pancreatic areas on contrast-enhanced CT scans.
The DUOnco™ Pancreas software is designed to aid radiologists by highlighting regions of interest within the pancreas during CT examinations. It assists in detecting areas, measuring their size, and assessing the main pancreatic duct's maximal diameter. Guerbet emphasizes that the AI is a supportive tool and does not replace the radiologist's interpretation or diagnosis.
Pancreatic cancer is a significant health concern in Japan, with high incidence and mortality rates. Early detection is crucial for treatment, but small or subtle lesions can be difficult to identify on CT scans. This PMDA certification is seen as a key step in the international rollout of DUOnco™ Pancreas, following its CE marking in Europe and a "Breakthrough Device designation" from the FDA in the United States.
Guerbet plans to partner with local IT providers in Japan to integrate DUOnco™ Pancreas seamlessly into radiologists' existing workflows. The company is also conducting further clinical research, including a collaboration with Kyushu University Hospital, to evaluate the software's performance on Japanese patient data and early-stage pancreatic cancer cases.