FDA de novo approval for GI Genius intelligent endoscopy module.- Medtronic.

Medtronic plc announced the FDA granted de novo clearance for GI Genius intelligent endoscopy module in the United States. 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 powerful new solution in the fight against colorectal cancer — the third most common form of cancer globally with 1.8 million new cases in 2018. Medtronic is the exclusive worldwide distributor of the GI Genius module, which was developed and is manufactured by Cosmo Pharmaceuticals. The GI Genius intelligent endoscopy module has received de novo clearance from the FDA . In addition to the United States, the GI Genius module is available in Europe and select markets in Asia, Australia and the Middle East. GI Genius provides endoscopists with a virtual second observer to assist in endoscopy exams. GI Genius works in real-time. It works as an adjunct to the gastroenterologist during a colonoscopy with the purpose of highlighting regions with visual characteristics consistent with different types of mucosal abnormalities, such as colorectal polyps of all shapes, sizes, and morphology. It is designed to be integrated with all existing colonoscopes. The device is approved in Europe with a CE Mark . According to Prof. Michael Wallace, Fred C. Andersen Professor of Medicine at Mayo Clinic and Editor in Chief of Gastrointestinal Endoscopy: "While colon cancer is the second deadliest cancer worldwide, it is the most preventable cancer yet full prevention remains unfulfilled. 1 in 20 US adult will be diagnosed with this disease in their lifetime but, encouragingly, 90% of patients can beat it if it is diagnosed early enough. Colonoscopy is the gold standard and most common screening method, but it's not perfect, as performance varies based on many factors including physician skill level. The GI Genius intelligent endoscopy module will help improve the accuracy of colonoscopy and reduce the number of undetected precancerous lesions, as has been shown in a recent randomized study (Repici et al.), where detection rates improved very significantly with GI Genius technology versus standard colonoscopy, regardless of skill level or endoscope used.".