Cosmo Pharmaceuticals announced today that it received marketing authorization for its GI Genius AI-based lesion detecting system.
GI Genius is an intelligent endoscopy system that uses AI/machine learning to detect lesions in the colon such as polyps or suspected tumors in real-time during a colonoscopy, according to a news release.
The device, which received FDA approval through the de novo pathway, is compatible with all endoscopes. Cosmo is the sole manufacturer, while Medtronic is the exclusive worldwide distributor.
Made up of hardware and software designed to highlight portions of the colon, the device uses AI algorithms to identify regions of interest where it may detect a potential lesion. GI Genius generates markers, which appear as green squares and are accompanied by a short, low-volume sound. It superimposes them on the video from the endoscope camera when a potential lesion is identified.
The device’s signals alert a clinician that further assessment, such as a closer visual inspection, tissue sampling, testing or removal/ablation of the lesion, could be needed.
“This approval is gratifying in many ways as it is aligned with our mission of serving markets with unmet needs,” Cosmo CEO Alessandro Della Chà said in the release. “Through our global distribution partnership with Medtronic, we are excited to pursue an opportunity that is worth at least $ 1.1 billion, looking only at the opportunity for artificial intelligence in the colonoscopy market. Leveraging on the strength of Medtronic’s large U.S. commercial footprint, we look forward to successfully and rapidly developing this market.”