Odin Medical AI Colon Polyp Detector

FDA has cleared an Odin Medical (an Olympus subsidiary) 510(k) for what it describes as the first cloud-based artificial intelligence technology to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. The Caddie computer-aided detection device was cleared based on data from a randomized controlled trial that demonstrated its potential to “enhance detection capabilities and patient care without increasing procedural risks or duration,” the company says. “The trial shows that use of the Caddie device improved the adenomas detected per colonoscopy, which is linked to cancer prevention.”

The device works by analyzing colonoscopy video in real-time and using visual markers to alert the endoscopist to the potential presence of polyps, Odin Medical says. Endoscopists would then review the the suspected polyp areas and confirm the presence or absence of a polyp based on their own medical judgment.