Medtronic Earns De Novo Clearance for AI Colonoscopy System

The FDA has granted Medtronic De Novo clearance for its GI Genius intelligent endoscopy module, an artificial intelligence (AI)-based system that identifies colorectal polyps that could develop into colon cancer.

The system, which identifies the presence of precancerous lesions in real time directly on the image using a green visual marker, is compatible with any colonoscope video.

The GI Genius module was trained using millions of actual images to identify and highlight abnormalities consistent with polyps, including small flat polyps that could otherwise go undetected during colonoscopies.