Odin Medical’s AI-powered device for colonoscopy receives FDA clearance

Editor's Note

Odin Medical, a subsidiary of Olympus Corporation, received Food and Drug Administration (FDA) 510(k) clearance for its cloud-based AI technology, the CADDIE™ computer-aided detection device, PRNewswire September 5 reports. Designed to assist gastroenterologists in detecting colorectal polyps during colonoscopy, the AI-powered system analyzes real-time video footage and alerts endoscopists to potential polyps, aiding early detection of colorectal cancer.

A multicenter trial in Europe demonstrated the efficacy of CADDIE in improving the adenoma detection rate without extending procedure time or increasing risks. This cloud-based system allows for seamless updates, ensuring healthcare providers have access to the latest AI advancements without additional infrastructure costs. However, while the device is meant to help clinical decision-making, it should not replace a physician’s judgment in detecting polyps.

Colorectal cancer is the second-leading cause of cancer deaths in the US, expected to claim over 53,000 lives in 2024. Medical innovation aims to reduce this burden by advancing screening technology through AI. The company sees the CADDIE device as a key component in improving the accuracy and efficiency of colonoscopies, helping to detect cancers earlier, especially as cases in people under 50 are projected to rise sharply by 2030.