GI Genius Module 100
Overview
The GI Genius™ Module 100 is a cutting-edge, computer-aided detection (CADe) system powered by artificial intelligence (AI) designed to assist endoscopists in real-time during colonoscopy procedures. Developed by Cosmo Artificial Intelligence – AI (also known as Cosmo Intelligent Medical Devices, a subsidiary of Cosmo Pharmaceuticals N.V.) and exclusively distributed worldwide by Medtronic, this module enhances the visualization of colonic mucosal lesions, such as polyps and adenomas. It processes real-time video from an endoscope, using advanced algorithms and computer vision techniques to identify suspicious regions and highlight them with visual markers. Studies have shown that the GI Genius™ module can significantly increase adenoma detection rates (ADR) and reduce the miss rate of colorectal polyps, thereby aiding in the early detection and prevention of colorectal cancer. It is compatible with existing endoscopy towers and high-definition endoscopes from various manufacturers, seamlessly integrating into current clinical workflows. The system is intended as an adjunct to colonoscopy and not as a replacement for clinical decision-making or histopathological sampling.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Real-time AI-assisted polyp detection during colonoscopy
- Enhanced visualization of colonic mucosal lesions
- 99.7% sensitivity rate for lesion detection
- Less than 1% false positives
- Compatible with existing endoscopy towers and high-definition endoscopes
- Universal compatibility with various endoscopic processors (e.g., Olympus, Fujifilm, Pentax)
- Overlays graphical markers to highlight suspicious regions
- Aids in detecting small, flat polyps that may be missed by the human eye
- Designed to host multiple AI software applications (via AI Accessu2122 Platform)
Use Cases
- Aid in detecting colonic mucosal lesions (polyps and adenomas) during screening colonoscopies
- Assist in surveillance endoscopic mucosal evaluations
- Reduce the miss rate of colorectal polyps and adenomas
- Improve adenoma detection rates (ADR) during colonoscopy
- Support early detection and prevention of colorectal cancer
What Physicians Need to Know
Leverage GI Geniusu2122 as a 'second observer' to enhance polyp detection, especially for subtle or flat lesions, and utilize the real-time visual markers to guide thorough inspection during colonoscopy. Be aware that while the system significantly improves ADR, it is an aid and does not replace clinical decision-making or the need for biopsy. Consider the benefits for improving consistency in detection rates, potentially mitigating variability among endoscopists or during longer procedures. Note that the system has not been studied in patients with Inflammatory Bowel Disease (IBD), and its performance might be negatively impacted by mucosal irregularities such as background inflammation from certain underlying diseases.
The GI Geniusu2122 Module 100 is designed for seamless integration with most existing endoscopy towers, high-definition endoscopes, video processors (e.g., Olympus, Fujifilm, Pentax), and display monitors. It connects in-line between the video processor and the display, utilizing standard SDI or HD-SDI ports. The system is intended to augment the current workflow without requiring significant changes to existing procedural steps.
Details
| Category | Gastroenterology AI |
| Pricing | Contact for pricing |
| Deployment | Integrates seamlessly with existing endoscopy tower, video processor, and display monitor in a clinical setting. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The GI Genius™ intelligent endoscopy module (including Module 100) received De Novo clearance from the U.S. FDA on April 9, 2021. It is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The device is limited for use with standard white-light endoscopy imaging only and is not intended to replace clinical decision making. |
| Integrations | |
| EHR | Not specified |
| Specialties | Colorectal Surgery, Gastroenterology |
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