Cosmo Pharmaceuticals NV announced the FDA approval of GI Genius intelligent endoscopy system, its revolutionary device for lesion detection during colonoscopy. The GI Genius module FDA approval marks a pivotal milestone for Cosmo after more than 10 years of research and investments focused to generate disruptive innovations in the field of colon's disease and optimization of the colonoscopy procedure. The development of GI Genius intelligent endoscopy module has been possible thanks to the leadership position of Cosmo, its unique proprietary library of high-definition loss-less videos of colonoscopies and its proprietary software and algorithms. The device is the first of its kind to obtain the FDA approval through the De Novo application. The device operates in real time to assist the endoscopist in the detection of lesions, is very simple to use and is compatible with all endoscopes. Cosmo is the sole manufacturer. Medtronic is the exclusive world-wide distributor.