Cosmo Intelligent Medical Devices' GI Genius Gets FDA Approval

The U.S. Food and Drug Administration (FDA) has officially cleared the latest iteration of Cosmo Intelligent Medical Devices' (Cosmo IMD) GI Genius hardware under the 510(k) process. This marks the sixth generation of the GI Genius system, which is distributed worldwide by Medtronic.

This advanced hardware aims to enhance physician capabilities by integrating cutting-edge AI technology during endoscopy procedures. A notable addition in this version is the FDA-cleared ColonPRO software, an AI-powered tool that assists endoscopists in detecting potential polyps and ensures consistent quality metric reporting in colorectal cancer screenings.

The newest iteration of GI Genius hardware offers:

1. Advanced AI Functionality: The module enhances the platform's AI capabilities, paving the way for the integration of cutting-edge AI features.
2. Flexible AI Application Support: By accommodating multiple AI applications, the module expands the platform's potential. This is made possible through a developer program spearheaded by Cosmo IMD in collaboration with Medtronic's commercial expertise.
3. Enhanced Connectivity: With upgraded connectivity options, the GI Genius hardware is designed to integrate seamlessly into healthcare systems, helping to standardize quality metrics and optimize procedural insights.
4. Energy-Conscious Design: The module is engineered for efficiency, delivering superior performance while consuming less energy, resulting in a quieter, more eco-friendly operation.
5. Consistent and Reliable Operation: Built with advanced hardware technologies, the module ensures real-time performance during medical procedures and supports a longer product lifespan.

These innovations stem from Cosmo IMD's engineering efforts, incorporating cutting-edge components like NVIDIA IGX Orin and NVIDIA Holoscan technologies. Cosmo IMD describes the GI Genius hardware as a groundbreaking development in endoscopic technology, offering healthcare providers continuously evolving AI tools to enhance patient outcomes.

Cosmo Intelligent Medical Devices President Nhan Ngo Dinh, said in a statement, “The GI Genius system sets a new standard in endoscopic technology. Our continuous innovation is driven by a commitment to enhancing patient care through AI. This FDA clearance marks a significant achievement, reinforcing our leadership in the field and our dedication to providing physicians with the tools they need to deliver exceptional medical outcomes.”

Cosmo Intelligent Medical Devices, a division of Cosmo Pharmaceuticals N.V., specializes in creating and bringing to market innovative solutions for gastrointestinal disorders, enhancing endoscopy quality through improved colonic lesion detection, and addressing specific dermatological conditions. Cosmo's products, including Lialda/Mezavant/Mesavancol, Uceris/Cortiment, Aemcolo/Relafalk, Lumeblue, and Winlevi, are distributed worldwide through strategic partnerships. Additionally, Cosmo has developed cutting-edge medical devices for endoscopy and collaborates with Medtronic for the global distribution of the GI Genius system.