FDA Clears AI Colonoscopy Tool Magentiq-Colo

The real-time system detects adenomas during colonoscopy procedures, with its maker planning a U.S. distribution network.

Updated on Nov. 3, 2026 in Cancer

Photograph of an empty modern endoscopy suite with a steel endoscopy tower and a coiled colonoscope on a clean tray under cool, even light. — The FDA has cleared Magentiq-Colo, an AI tool that flags adenomas in real time during colonoscopy, as its maker plans a U.S. distribution network. AI Illustration. Upload story photo >

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Would you trust an AI tool to help your doctor catch polyps during a colonoscopy?

The FDA has cleared Magentiq-Colo, an AI-powered colonoscopy tool that detects adenomas in real time. The device previously received approvals from Israel AMAR and the European CE Mark in mid-2021.

Why it matters

Each year, 15 million to 20 million colonoscopies are performed, and an estimated 8% to 10% of colorectal cancers begin with a missed polyp. A tool that improves adenoma detection targets that gap at a national scale.

The validation study enrolled over 950 patients and involved 29 endoscopy experts, showing a 26% relative (7% absolute) rise in adenoma detection. Whether the reported 35% mortality and 21% colorectal cancer reductions will hold over time remains unclear from the available data.

The players

Magentiq-Eye

The Israeli medical technology company that developed Magentiq-Colo and plans to pursue opportunities in the U.S. market.

U.S. Food and Drug Administration (FDA)

The federal agency that granted 510(k) clearance to Magentiq-Colo for use in the United States.

The details

Magentiq-Colo works in real time during colonoscopy to flag adenomas for the endoscopist. It is distributed through a local U.S. subsidiary and an agent network that is still being established.

Mid-2021: Israel AMAR and European CE Mark approvals received.
2022: Validation study with over 950 patients conducted.
November 3, 2026: FDA clearance reported.

Health Landscape

Computer-aided detection systems for colonoscopy have been developed to address the missed-polyp problem that drives a share of colorectal cancers. Magentiq-Colo adds to this category by offering real-time adenoma flagging now cleared for U.S. use.

For patients undergoing colonoscopy, a tool that flags polyps in real time could reduce the chance that a precancerous growth is overlooked. Availability will depend on whether providers adopt the device once U.S. distribution is established.

The takeaway

Regular colonoscopy remains the central screening tool for colorectal cancer, and new detection aids are designed to support rather than replace the procedure. Patients should discuss screening schedules and any available technology with their doctors.