Intrasense and Guerbet Secure Japan Nod for Pancreatic AI

Intrasense and Guerbet have secured PMDA certification in Japan for DUOnco™ Pancreas, an AI-powered software designed to support pancreatic CT scan analysis. The approval expands the companies’ push into AI-assisted medical imaging following earlier milestones in Europe and th

French medical imaging companies Intrasense and Guerbet have received PMDA certification in Japan for DUOnco™ Pancreas, an AI-powered software designed to support radiologists in reading pancreatic regions on contrast-enhanced CT scans.

According to the companies, the software is believed to be the first pancreas-focused AI imaging tool to receive certification in Japan.

The approval comes as pancreatic cancer continues to pose a major healthcare challenge globally and particularly in Japan, where more than 47,000 new cases and over 43,000 deaths were recorded in 2022. Early diagnosis remains difficult because pancreatic tumors are often small, hard to detect on CT scans, and may not show clear symptoms in early stages.

DUOnco™ Pancreas is designed to assist radiologists by highlighting regions of interest in the pancreas, measuring suspicious areas, and evaluating the main pancreatic duct. The companies clarified that the software is intended as a support tool and does not replace physician interpretation or diagnosis.

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Intrasense and Guerbet said they plan to integrate the software into existing radiology workflows in Japan through collaborations with PACS vendors and local imaging IT partners, allowing radiologists to use the tool within their existing viewing environments.

The certification follows the product’s CE marking in Europe earlier this year and its FDA Breakthrough Device designation in the United States.

The companies are also continuing clinical research collaborations in Japan and Europe, including an ongoing project with Kyushu University Hospital focused on evaluating the software’s performance in detecting early pancreatic cancer cases.

“By utilizing this AI, incidental detections in the pancreas are expected to increase, potentially enabling cancer treatment at an earlier stage,” said Professor Kousei Ishigami of Kyushu University Hospital.

Stephen Armand, CEO of Intrasense, said the company aims to work closely with local partners in Japan to ensure smooth integration into radiologists’ existing systems and workflows.

François Nicolas, SVP Research, Development, Innovation and AI at Guerbet, added that the software was developed using insights gathered from more than 100 medical institutions across Japan.

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