GI Genius is a deep learning, computer-aided polyp detection system developed by Cosmo Intelligent Medical Devices, a fully-owned subsidiary of the Ireland-based pharmaceutical company Cosmo Pharmaceuticals, to detect colorectal polyps and lesions during colonoscopy that may potentially develop into cancer.
Medtronic, a medical device company, markets the device worldwide as a global partner of Cosmo.
The US Food and Drug Administration (FDA) granted de novo clearance for the GI Genius system in April 2021. The system is also approved in Europe as a CE-marked medical device. It is also available in select Asian, Australian, and the Middle East markets.
Medtronic received a contract to install 115 GI Genius systems at several US Department of Veterans Affairs medical facilities across the US, through collaboration with a Service-Disabled Veteran-Owned Small Businesses in October 2022. It provides veterans with access to AI-assisted colon cancer screening during colonoscopy.
The Richmond McGuire VA Medical Center is the first hospital to be installed with GI Genius module for colorectal cancer screenings for veterans.
In March 2023, Cosmo collaborated with NVIDIA, a software company based in the US, to integrate NVIDIA’s AI technologies into the GI Genius endoscopy device to bring new AI-based solutions into patient care for making better clinical decisions and alleviating medical variability for improved patient outcomes.
Medtronic will donate 133 GI Genius systems to 62 endoscopy facilities in the US to serve low-income and underserved communities through the Medtronic Health Equity Assistance Programme for colon cancer screening, supported by Amazon Web Services.
GI Genius design and features
GI Genius is an intelligent endoscopy module that utilises advanced AI to mark lesions with a visual marker at precancerous stage in real time, which may go unnoticed by the human eye.
It uses advanced algorithms to process images, which detect and mark abnormalities in polyps, such as small flat polyps.
The GI Genius system is designed to accommodate several AI algorithms and can automatically detect colorectal polyps, regardless of shape, size, and morphology, in real time.
It is capable of being seamlessly integrated with all major existing brands of endoscopic 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, in standard white-light endoscopy examinations undergoing mucosal evaluations in real time.
The system is universally compatible and is a second vigilant observer during colonoscopy, which can improve adenoma detection rate (ADR) and help in reducing the risk of colorectal cancer.
GI Genius system efficiency details
The GI Genius module has a 99.7% sensitivity rate with less than 1% false activations. It recognises polyps 82% faster than an endoscopist in real time.
Studies revealed that GI Genius system’s AI can increase ADR during screening colonoscopy, and each 1% ADR reduces the risk of colorectal cancer by 3%.
An examination of 300,000 colonoscopies conducted by 136 gastroenterologists showed that ADR ranged between 7.4% and 52.5%.
GI Genius AI Access platform details
Cosmo introduced the Innovation Center website with the integration of NVIDIA’s Holoscan, a real-time AI computing software platform for building medical devices, and IGX, an industrial-grade AI hardware platform. It allows third-party developers with a cloud platform to build and test their AI models for medical procedures to finally distribute them through the GI Genius module.
Further, the AI-driven applications are hosted on the GI Genius AI Access platform, which is a marketplace for software-as-a-medical-device applications. The AI-assisted colonoscopy system will assist healthcare professionals with AI-enhanced diagnostic images.
The integration of the NVIDIA Clara healthcare platform with GI Genius can facilitate the scaling up of the development of algorithms for real-time procedures for Medtronic, which may improve AI innovation for improved patient care.
The first GI Genius system built using NVIDIA technology will be available in late 2023.
Clinical trials on GI Genius intelligent endoscopy module
The safety and efficacy of the GI Genius system was assessed in a randomised, international, multicentre clinical study named DETECT, which was conducted in the US and Europe, including Italy and the UK.
A total of 249 participants were enrolled in the study, of which 229 completed the study and were included in the primary efficacy analysis. They were randomised to receive either a GI Genius-assisted colonoscopy or a standard white-light colonoscopy.
The primary endpoint of the study was the adenoma miss rate (AMR), which was the percentage of adenomas or carcinomas that were found at the second colonoscopy, which was not detected at the first colonoscopy.
The study found that the patients achieved a significantly lower AMR with GI Genuis in the first colonoscopy compared to the white-light endoscopy used in the first colonoscopy. GI Genius reduced missed polyp rate by about 50% on initial colonoscopy compared to standard colonoscopy.
The clinical trial results demonstrated that the use of GI Genius significantly reduces the miss rate of both adenomas and polyps, further confirming the advancements that the system brings to colonoscopy procedures.