Olympus Corporations’ Odin Medical receives US FDA clearance for first cloud-based AI endoscopy system for colonoscopy

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

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.

CADDIE device improves adenomas detected per colonoscopy, as demonstrated in a trial conducted across eight medical centers in Europe. 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.

Miquel Àngel García, Global Head of Endoscopy Solutions Ecosystem at Olympus Corporation said, "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 healthcare 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.