The CADDIE computer-aided detection (CADe) device is designed to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. In this image, the CADDIE device indicates the potential presence of a diminutive polyp. This image is for illustration purposes only. It is not a representation of an actual product as it may be commercialized.
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.
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.
“The trial shows that use of the CADDIE device improved the adenomas detected per colonoscopy, which is linked to cancer prevention. The potential for this system to support more endoscopists in helping more patients is truly exciting,” said Professor Alessandro Repici, chairman, department of gastroenterology at Humanitas University & Humanitas Research Hospital, Italy, and principal investigator of the trial.
The CADDIE device works by analyzing colonoscopy video in real-time and using visual markers to alert the endoscopist to the potential presence of polyps. The endoscopist is responsible for reviewing the CADDIE device’s suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment.
“As a global leader in endoscopy, it is our vision to make AI a key component of our digital transformation,” said Miquel Àngel García, global head of endoscopy solutions ecosystem at Olympus Corporation. “Odin’s success with this FDA clearance is an important step forward. A digitally transformed endoscopy ecosystem has the potential to support doctors and hospitals as they navigate global industry mega trends like cost pressures and staff shortages, in the context of an aging population. We are very excited about the huge opportunities for patients and health care systems that these advancements make possible.”
The CADDIE device is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. The CADDIE device is limited to use with standard white-light endoscopy imaging only.
