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FDA Authorizes GI Genius As A Smarter AI-Based Colonoscopy Tool

According to a large clinical study, the first such device with AI-enabled software is better at detecting potential lesions than traditional colonoscopies and could allow detection of colon cancer sooner.

Physicians examining a patient during a colonoscopy

The US Food and Drug Administration has given de novo authorization to Medtronic plc and Cosmo Pharmaceuticals N.V.’s GI Genius endoscopy module. The device is the first of its kind to use artificial intelligence to help detect lesions during a colonoscopy, which could have major implications for fighting colon cancer.

The agency announced on 12 April that it had granted marketing authorization to the product, which has been trained to spot polyps and potential tumors using machine learning. The GI...

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