Medi-Globe has announced the launch of mAI Companion, a real-time medical AI solution designed to assist physicians in detecting pancreatic lesions during endoscopic ultrasound (EUS), addressing what it says is one of the deadliest and most difficult-to-detect cancers, where earlier identification can dramatically change patient outcomes.
Developed through a multi‑year collaboration with IHU Strasbourg, mAI Companion has received MDR CE Mark certification, becoming the first‑of‑its‑kind AI assistant for pancreatic EUS approved for clinical use in Europe.
Pancreatic cancer remains one of the deadliest malignancies worldwide, and early detection can significantly improve survival. EUS provides high‑resolution, close‑up imaging and allows targeted biopsy confirmation, but the technique demands years of experience, and subtle lesions can still be difficult to detect.
mAI Companion functions as an intelligent “second set of eyes” during EUS, automatically analysing the head, body, and tail of the pancreas in real time to highlight solid and cystic lesions that may otherwise go unnoticed.
The expected result: greater diagnostic confidence, more systematic exams, and fewer missed findings supporting earlier identification of pancreatic lesions including stages when treatment options and survival outcomes are significantly improved.
mAI Companion was created in collaboration with leading European expert centres and trained on hundreds of real‑patient EUS videos containing more than five million expert‑annotated images. Each annotation was validated by experienced endoscopists, enabling the software to act like a trusted expert advisor beside the clinician.
mAI Companion underwent first‑in‑human clinical use ahead of market introduction, a milestone Medi-Globe first reported in 2022. Patents covering key elements of the technology have been filed. A tandem randomised EUS video trial involving 57 endoscopists, currently under peer‑review, demonstrated significantly higher diagnostic accuracy and a marked reduction in missed‑lesion rates when using AI compared with standard assessment.
Together, these benefits drive more confident exams, more consistent results, and better patient outcomes, reinforcing trust and institutional excellence in pancreatic EUS. Earlier and more reliable lesion detection supports faster diagnosis, earlier treatment decisions, and ultimately improved patient pathways in a disease where time is critical.
“This product will revolutionise pancreatic care going forward – saving patients’ lives and making our job as physicians easier. Medi‑Globe moved faster to market than any similar effort I’ve seen, and deserves kudos for bringing the first in the world AI augmented EUS product to market. The collaboration with our R&D team and the preeminent Scientific advisory board has been excellent from start to finish. The development of mAI Companion should serve as a model for the future introduction of AI medical devices into interventional endoscopic practice.” said Prof. Dr. Lee Swanstroem, Interventional Endoscopist, Oregon Health and Science University, Portland Oregon USA and Director Emeritus, IHU-Strasbourg Institute of Image Guided Surgery, Strasbourg, France
Dr. Leonardo Sosa Valencia, Clinical Gastroenterologist, Digestive Echo Endoscopist, Medical Staff Manager at IHU, Strasbourg, France said: “When we started the research project at the IHU in Strasbourg seven years ago, it was a dream to develop a product that would help endosonographers to do a complete pancreatic evaluation. Now that dream has become reality.
“I see mAI Companion as a great opportunity in medicine for more gastroenterologists to offer their patients high and consistent quality in the performance of pancreatic endoscopic ultrasound that will lead to a early diagnosis of pancreatic diseases and cancer, and I am convinced that this AI will help us doctors save patients’ lives. mAI Companion will be my companion.”
Marc Jablonowski, Managing Director, Medi-Globe, Rohrdorf, Germany added: “This is a major milestone for Medi-Globe. Turning mAI Companion from concept to clinical reality required close collaboration with our partners at IHU Strasbourg and a broad international medical advisory network. Our goal is to provide clinicians with practical, workflow-integrated AI support that increases quality, confidence and consistency in pancreatic EUS.”
Dr. Markus Schönberger, President, iGlobe Scientific, Strasbourg, France said: “Delivering this programme on time and on budget reflects our disciplined approach from early prototype through MDR CE Mark, combining rigorous engineering, close clinical collaboration, and a strong focus on quality and compliance.”
With CE-marked approval, mAI Companion is now cleared for clinical use across the EU, with initial deployments underway at leading European centres and broader rollout planned. For demonstrations or purchasing inquiries, contact Medi-Globe.
