FDA Clears AI-Assisted Colonoscopy Device

The US Food and Drug Administration (FDA) has approved an AI-assisted colonoscopy device called MAGENTIQ-COLO. The device helps identify lesions in real-time and has been found to increase the adenoma detection rate (ADR). It received clearance under the FDA’s 510(k) process and has already received approval in Europe and Israel.

The device was validated in a study in 2022, which showed that it increased ADR by 26% and led to a decrease in colorectal cancer occurrence and patient mortality. The device breaks down colonoscopy videos into frames and uses AI to detect polyps, helping doctors identify them.
Conventional colonoscopies can miss a quarter of adenomas, leading to the development of AI systems that aim to improve detection rates. Despite regular screenings, missed polyps during colonoscopies can still put patients at risk of developing colon cancer.

Better detection could prevent over 13,500 cancer cases in the US each year. Colorectal cancer is the third leading cause of cancer-related death in the US, according to the National Institutes of Health.