First Cloud-Based AI Endoscopy System for Colonoscopy Receives FDA Clearance

September 5, 2024
10:19 am

CENTER VALLEY, Pa., Sept. 5, 2024 /PRNewswire/ -- Odin Medical Ltd., an Olympus Corporation company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the first cloud-based Artificial Intelligence (AI) technology designed to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures, the CADDIE™ computer-aided detection (CADe) device.

In the constantly evolving, fast-paced world of AI, this innovative cloud-based technology supports doctors to improve the detection of the early signs of colorectal cancer using AI software that can be remotely updated. The flexibility, speed-to-innovation, and potential cost-savings of a cloud-based system are designed to help endoscopists provide a high level of care to patients.

“Together with Olympus, we are proud to bring this groundbreaking technology to the U.S. The cloud gives us the ability to keep hospitals up-to-date with advances in AI and gives peace of mind to doctors that they can easily access current technology for their patients,” said Peter Mountney, Ph.D., CEO of Odin Vision.

CADDIE^™ device improves adenomas detected per colonoscopy
A prospective, multi-center randomized controlled trial successfully demonstrated the efficacy and safety of the CADDIE device, underscoring its potential to enhance detection capabilities and patient care without increasing procedural risks or duration. The trial was conducted across eight medical centers in Europe.

First Cloud-Based AI Endoscopy System for Colonoscopy Receives FDA Clearance

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