October 15, 2024

Olympus Corporation (hereinafter referred to as Olympus) regionally managing company in Europe, Olympus Europa SE & Co. KG (hereinafter referred to as OEKG), announces that three cloud-based AI endoscope image diagnosis support systems developed by group company Odin Medical Ltd. (hereinafter Odin Vision, headquartered in London, UK) have obtained CE marking certification based on the European Medical Devices Regulation (MDR). The products that obtained the CE mark this time, "CADDIE", "CADU", "SMARTIBD", will be important milestones in contributing to the improvement of clinical outcomes and operational efficiency in endoscopic examinations by Olympus.

With the certification obtained, Olympus has taken a significant step forward towards the commercialization of its new solution for medical endoscopes, the "Intelligent Endoscope Medical Ecosystem". This ecosystem aims to support diagnostic during endoscopic examinations using data and AI, contributing to the improvement of operational efficiency. It connects hardware, software, services, and data to aim at resolving medical issues in the endoscopy field.

"CADDIE" assists physicians in detecting and diagnosing suspected colon polyps or early colon cancer lesions during colonoscopy. Equipped with both cloud-based computer-aided detection (CADe) and computer-aided diagnosis (CADx) functions, it supports visual judgment by the physician on areas where lesions are suspected.

"CADU" supports physicians in detecting Barrett's esophagus abnormalities during endoscopic examinations.

"SMARTIBD" is an AI that assists in scoring the state of ulcerative colitis during colonoscopy.

All three products utilize Odin Vision's innovative cloud technology applied AI algorithms, enabling real-time data analysis via the cloud and software updates. None of the products aim to replace the diagnostic procedures carried out by physicians on patients.

Olympus is currently conducting a pilot program of a cloud-based AI endoscope image diagnostic support system at some medical institutions in Europe, evaluating and improving in actual clinical settings to meet the unmet needs of medical professionals and patients. Once the pilot program is completed, Olympus plans to start commercializing these three products in EMEA in the first quarter of the fiscal year ending March 2025.

For more details, please refer to the English press release announced by OEKG on October 14, 2024 (European time).

*1 The CE mark indicates that the product complies with the standards and requirements of EU (European Union) directives.

*2 'CADDIE,' 'CADU,' and 'SMARTIBD' are products that are not approved under the Pharmaceutical and Medical Device Act in Japan.

*3 'CADDIE' has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for CADe functionality only.

Olympus aims to achieve the health, safety, and enrichment of people around the world as our purpose. We, as a leading global medtech company, will contribute to improving the medical standards for the target disease by providing optimal solutions and services that assist in the early detection, diagnosis, and low-invasion treatment of the lesions, in collaboration with medical professionals. Since our founding over 100 years ago, we will continue to aim to contribute to society by providing products that bring optimal value to customers worldwide. For more information, please visit the Olympus official website () and X (@ Olympus_Corp_JP).