April 12, 2021 – Medtronic plc (Dublin, Ireland) announced that the U.S. Food and Drug Administration (FDA) granted de novo clearance for GI Genius intelligent endoscopy module in the United States.
According to the company, the GI Genius module is the first and only commercially available computer-aided detection (CADe) system using artificial intelligence (AI) to identify colorectal polyps. The module, compatible with any colonoscope video, provides physicians with a new solution in the fight against colorectal cancer.
The GI Genius module uses advanced AI to highlight the presence of precancerous lesions with a visual marker in real-time. It processes images using advanced algorithms that can identify and mark abnormalities consistent with polyps, including small flat polyps that might otherwise go undetected by the human eye.
Medtronic is the exclusive worldwide distributor of the GI Genius module, which was developed and is manufactured by Cosmo Pharmaceuticals. In addition to the United States, the GI Genius module is available in Europe and select markets in Asia, Australia and the Middle East.