The FDA has granted 510(k) clearance to the first cloud-based artificial intelligence device designed to assist in detecting suspected colorectal polyps during colonoscopy procedures.
CADDIE (Odin Medical Ltd.) analyzes colonoscopy video in real-time, using visual markers to alert physicians to potential polyps.
A prospective, multi-center randomized controlled trial conducted across eight medical centers in Europe successfully demonstrated improved adenoma detection per colonoscopy with CADDIE use, while also confirming its safety.
The system's cloud connectivity enables remote updates, potentially offering flexibility and rapid integration of AI advancements. However, the device is limited to use with standard white-light endoscopy imaging.
"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, PhD., CEO of Odin.
The system is part of a broader trend toward incorporating AI into medical diagnostics and procedures. As with all AI-assisted medical technologies, clinicians should remain aware of the system's limitations and continue to rely on their medical judgment for patient care decisions.
