Cosmo Announces EU MDR Certification for Endovision's Cerebro, expanding its real-time AI ecosystem
- Expansion of AI capabilities to upper gastrointestinal tract, complementing existing lower GI solutions
- EU MDR certification achieved, enabling market access in Europe
- Integration with Medtronic GI Genius system provides established distribution channel
- Technology supports multiple imaging modalities including White-Light, NBI, TXI, and BLI
- None.
Dublin, Ireland--(Newsfile Corp. - May 2, 2025) - Cosmo is excited to announce that Endovision Limited, a leading innovator in endoscopic imaging solutions, has received EU MDR certification[1] for Cerebro, a Real-Time AI-powered guide for complete Esophagogastroduodenoscopy (EGD) procedures. As one of the first Computer-Assisted Quality (CAQ) tools for endoscopy, Cerebro marks a significant step forward in transforming procedures by elevating inspection quality, standardizing protocols, and ultimately enhancing patient outcomes. Cerebro software is intended to be distributed later this year via the AI Access™ platform integrated into the Medtronic GI Genius™ intelligent endoscopy system, which is manufactured by Cosmo.
Cerebro leverages advanced deep learning algorithms to analyse real-time endoscopic imaging, integrating seamlessly with multiple modalities – including White-Light, NBI, TXI, and BLI – to highlight critical anatomical landmarks and identify potential quality issues during EGD procedures. Using a robust, data-driven approach developed from extensively annotated datasets, Cerebro standardizes inspection protocols and generates detailed photo documentation, complete with coverage scores and procedural reports.
With Cerebro, Cosmo’s real-time AI platform will extend its capabilities to the upper gastrointestinal tract, seamlessly complementing the established success in lower GI procedures. This release aligns with the ecosystem's aim to support all endoscopists with AI during their procedures, bridging the gap between technology innovation and its translation into better patient care.
Endovision has been collaborating with the Faculty of Medicine at the Chinese University of Hong Kong (CUHK) to advance this technology. Prof. Philip Chiu, Dean of the Faculty of Medicine at CUHK and a leading pioneer in the field of endoscopy, AI, and early diagnosis, shared, “it is deeply rewarding to see this technology evolve from my initial concept to clinical translation with the potential to significantly improve patient outcomes.”
Highlighting the system’s precision, Dr. Yuichi Mori, Professor at the Faculty of Medicine, University of Oslo, and a leading figure in the advancement of early diagnosis and AI-driven endoscopic technologies, stated: “Cerebro assists endoscopists in navigating all key landmark points in the upper GI tract, ensuring a comprehensive and thorough examination without blind spots. The system operates with exceptional accuracy when the endoscope is maneuvered slowly, allowing for clear visualization of the landmarks, which ultimately enhances the quality of endoscopy. I am excited to witness how AI-driven technologies like this continue to improve patient care through improved endoscopy quality.”
Saurabh Jejurikar, CEO of Endovision Limited, commented: “Achieving MDR certification underscores our team’s ability to innovate, develop, and secure approval for groundbreaking AI solutions.” Regarding the collaboration with Cosmo, he added: “I’m proud of making available our product in the most advanced real-time AI ecosystem available today. Building on top of it, we are now leading the way toward a new era of standardization through Computer-Aided Quality (CAQ) in endoscopy.”
“It is exciting to see how our ecosystem is reducing the barriers to the adoption of responsible AI into clinical practice,” said Nhan Ngo Dinh, President of Cosmo Intelligent Medical Devices. He added: “This is a perfect example of how software-defined medical devices can change the pace of innovation and, simultaneously, demonstrates once more the effectiveness of our strategy to translate Artificial Intelligence into real patient benefits.”
About Endovision
Endovision develops AI software for Upper GI endoscopy, enhancing procedural quality. Based in Hong Kong and India. For more information, please see: https://www.endovisionai.com/.
About Cosmo
Cosmo Pharmaceuticals N.V. is committed to revolutionizing healthcare and transforming people’s lives by researching and developing innovative products that tackle unfulfilled healthcare demands. As a pharmaceutical company, Cosmo is active in the areas of Healthtech/AI, dermatology, gastroenterology and contract manufacturing & development. For the commercialization and distribution of its products, Cosmo collaborates with leading partners worldwide, including Medtronic and Sun Pharma. Founded in 1997, Cosmo is headquartered in Dublin (Ireland) and has offices also in San Diego (USA), and Lainate/Rome/Catania (Italy). The Company has approximately 330 employees at the end of 2024, all dedicated to making a significant impact in the field of healthcare. For more information, please visit www.cosmopharma.com.
Financial calendar
| Ordinary Annual General Meeting of Shareholders | May 30, 2025 |
| Jefferies Healthcare Conference, New York | June 3-5, 2025 |
| Investor Day, Zurich | July 1, 2025 |
| 2025 Half-Year Results and Report | July 23, 2025 |
For further information, please contact:
Endovision Limited: Saurabh Jejurikar, CEO, saurabh@endovisionai.com
Cosmo Pharmaceuticals: Investor Relations, investor.relations@cosmopharma.com
Disclaimer
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.
[1] Notified Body: DQS Medizinprodukte GmbH, identification number 0297
Attachments
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FAQ
What is Cosmo's (CMOPF) Cerebro AI system and what does it do?
When will Cosmo's (CMOPF) Cerebro be available in the European market?
What imaging modalities does Cosmo's Cerebro AI system support?
How does Cerebro enhance Cosmo's (CMOPF) existing AI capabilities?
