Cosmo Intelligent Medical Devices Wins FDA Nod for GI Genius Hardware

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Cosmo Intelligent Medical Devices’ (Cosmo IMD) next-generation GI Genius hardware, the latest development of the GI Genius intelligent endoscopy system that is globally distributed by Medtronic. 
 
Now in its sixth generation, the GI Genius hardware is engineered to elevate physician performance with sophisticated artificial intelligence (AI)-driven insights during patient procedures. This latest iteration includes the FDA-cleared ColonPRO software, the GI Genius AI colon application designed to help endoscopists identify potential polyps and standardize quality metric reporting during colorectal cancer screenings.
 
Features of the latest GI Genius hardware include:

• Enhanced AI Capabilities: The module extends the platform’s ability to support innovations in AI and enables acceleration towards exciting new AI features.
• Versatile AI App Integration: The module is capable of hosting multiple AI apps, significantly broadening the platform’s utility, through a developer program led by Cosmo IMD with Medtronic’s¹ commercial leadership. 
• Improved Connectivity: With additional interconnectivity options, the GI Genius hardware potentially integrates seamlessly within the healthcare system to standardize quality metrics and procedure highlights.
• Energy Efficiency: The module design achieves more with less energy, ensuring a quiet, efficient, and environmentally-friendly operation.
• Reliable Performance: It integrates hardware technologies to support real-time performance during medical procedures and an extended product lifecycle. 

These advancements were realized through Cosmo IMD’s engineering using state-of-the-art components such as NVIDIA IGX Orin and NVIDIA Holoscan technologies.
 
The GI Genius hardware represents a new frontier in endoscopic technology, providing healthcare professionals with continuously evolving AI capabilities to enhance patient care, according to Cosmo IMD. 

“The GI Genius system sets a new standard in endoscopic technology,” Cosmo Intelligent Medical Devices President Nhan Ngo Dinh said. “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 is a a division of Cosmo Pharmaceuticals N.V., which develops and commercializes products to treat selected gastrointestinal disorders, improve endoscopy quality measures through colonic lesion detection, and treat selected dermatological conditions. Cosmo develops and manufactures products that are distributed globally by selected partners including Lialda/Mezavant/Mesavancol, Uceris/Cortiment, Aemcolo/ Relafalk, Lumeblue, and Winlevi. Cosmo has also developed medical devices for endoscopy and has a partnership with Medtronic for the global distribution of GI Genius. 

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¹ Existing GI GeniusTM hardware can also be upgraded to host multiple independent AI applications. More communication with current customers will be forthcoming.