The U.S. Food and Drug Administration (FDA) announced de novo clearance of GI Genius™, a revolutionary AI device for colonoscopy. The device is the first of its kind, and was developed by Cosmo Pharmaceuticals, with exclusive distribution rights to Medtronic. Operating in real time, the AI computer-aided detection (CADe) system identifies colorectal polyps. The CEO of Cosmo, Alessandro Della Chà, stated, “This approval is gratifying in many ways as it is aligned with our mission of serving markets with unmet needs. Through our global distribution partnership with Medtronic we are excited to pursue an opportunity which is worth at least $ 1.1bn, looking only at the opportunity for artificial intelligence in the colonoscopy market. Leveraging on the strength of Medtronic’s large US commercial footprint, we look forward to successfully and rapidly developing this market.”
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