GI Genius is the first FDA-cleared AI-assisted colonoscopy system that helps doctors detect colorectal polyps that can lead to cancer. Credit: Medtronic.
The GI Genius intelligent endoscopy module helps diagnose and prevent colorectal cancer. Credit: Medtronic.
The system uses AI to process images to identify lesions and abnormal polyps that cannot be detected by the human eye. Credit: Medtronic.
GI Genius is a deep learning, computer-aided polyp detection system developed by Cosmo Intelligent Medical Devices, a wholly owned subsidiary of Ireland-based pharmaceutical company Cosmo Pharmaceuticals, that detects polyps that have the potential to develop into cancer during a colonoscopy. It is used to detect colorectal polyps and lesions.
Medtronic, a medical device company, is Cosmo’s global partner and sells the device around the world.
The U.S. Food and Drug Administration (FDA) granted new approval for the GI Genius system in April 2021. The system is also approved as a CE marked medical device in Europe. Also available in select Asian, Australian and Middle Eastern markets.
In October 2022, Medtronic signed a contract to install 115 GI Genius systems at multiple Department of Veterans Affairs medical facilities across the United States through a partnership with Disabled Veteran-Owned Small Businesses. This will give veterans access to AI-assisted colon cancer. Screening during colonoscopy.
Richmond McGuire VA Medical Center is the first hospital to implement the GI Genius module for colorectal cancer screening for veterans.
In March 2023, Cosmo collaborated with NVIDIA, a US-based software company, to integrate NVIDIA’s AI technology into the GI Genius endoscopic device, bringing new AI-based solutions to patient care and Make better clinical decisions and reduce variation in care for patient improvement. result.
Through the Medtronic Healthcare Equity Assistance Program for Colon Cancer Screening, supported by Amazon Web Services, Medtronic is working with 62 of the United States to serve low-income and underserved communities. We will donate 133 GI Genius systems to endoscopy facilities.
GI Genius design and features
GI Genius is an intelligent endoscopy module that uses advanced AI to mark precancerous lesions in real time with visual markers that are invisible to the human eye.
It uses advanced algorithms to process images to detect and mark polyp anomalies such as small flat polyps.
The GI Genius system is designed to support several AI algorithms and can automatically detect colorectal polyps in real time, regardless of their shape, size, or morphology.
It integrates seamlessly with all existing major brand endoscope processors such as Olympus, Fujifilm, and Pentax.
The AI-powered computer-assisted reading tool is designed to help endoscopists identify colonic mucosal lesions, such as polyps and adenomas, during standard white-light endoscopy with real-time mucosal assessment.
The system is widely compatible and serves as a second vigilance observer during colonoscopy, improving adenoma detection rate (ADR) and helping reduce the risk of colorectal cancer.
GI Genius System Efficiency Details
The sensitivity rate of the GI Genius module is 99.7%, with less than 1% false activation. Recognizes polyps 82% faster than endoscopists in real time.
Study reveals that the GI Genius system’s AI can increase ADR during colonoscopy screening, with each 1% ADR reducing colorectal cancer risk by 3% .
A study of 300,000 colonoscopies performed by 136 gastroenterologists showed ADRs ranging from 7.4% to 52.5%.
Learn more about the GI Genius AI Access platform
Cosmo has introduced an Innovation Center website that integrates NVIDIA’s Holoscan, a real-time AI computing software platform for building medical devices, and IGX, an industrial-grade AI hardware platform. This will enable third-party developers using the cloud platform to build and test AI models for medical procedures and ultimately distribute them through his GI Genius module.
Additionally, AI-driven applications are hosted on the GI Genius AI Access platform, a marketplace for software applications as medical devices. The AI-assisted colonoscopy system assists medical professionals with AI-enhanced diagnostic images.
The integration of GI Genius with the NVIDIA Clara healthcare platform will help Medtronic scale up algorithm development for real-time procedures, potentially improving AI innovation and improving patient care.
The first GI Genius systems built using NVIDIA technology are expected to be available in late 2023.
Clinical trial of GI Genius intelligent endoscope module
The safety and effectiveness of the GI Genius system was evaluated in a randomized, international, multicenter clinical study called DETECT. The study was conducted in the United States and Europe, including Italy and the United Kingdom.
A total of 249 participants were enrolled in the study, of whom 229 completed the study and were included in the primary efficacy analysis. They were randomly assigned to undergo GI Genius-assisted colonoscopy or standard white-light colonoscopy.
The study’s primary endpoint was adenoma miss rate (AMR), which was the proportion of adenomas or carcinomas found at a second colonoscopy that were not detected at the first colonoscopy.
This study found that patients who used GI Genuis at their first colonoscopy achieved significantly lower AMR compared to the white light endoscope used at their first colonoscopy. did. GI Genius reduced the rate of missed polyps at initial colonoscopy by approximately 50% compared to standard colonoscopy.
Clinical trial results demonstrated that the use of GI Genius significantly reduced missed rates of both adenomas and polyps, further supporting the advancements this system brings to colonoscopy procedures.
