Cosmo Artificial Intelligence-AI Ltd has announced a novel clinical trial aiming to explore the integration of GI Genius™ XR software with virtual reality (VR) headsets during routine colonoscopies. This innovation opens new avenues for enhancing visualization and accuracy in detecting colorectal abnormalities. As of October 2025, the trial’s recruitment phase remains open.
What changed?
GI Genius™ XR software is being evaluated for its capabilities to aid physicians in real-time during colonoscopies through VR technology. This trial marks a shift towards utilizing augmented tools in routine clinical settings, adding a new technological layer to the established procedure of colonoscopy.
What does the trial focus on?
The primary intervention in this clinical trial involves the utilization of GI Genius™ XR software integrated into VR headsets. Physicians conducting colonoscopies would use this technology to enhance diagnostic accuracy and visualize areas of concern efficiently. Sponsored by Cosmo Artificial Intelligence-AI Ltd, the aim is to assess whether this tool improves outcomes and workflow without impeding standard procedural protocols.
Who is involved?
Cosmo Artificial Intelligence-AI Ltd stands as the sponsor for this trial. The potential participants or impacted demographics will likely include clinicians experienced in gastrointestinal procedures, colorectal specialists, and regulatory bodies overseeing safety in medical device usage.
Will there be immediate implications?
Since the trial is still in the “not yet recruiting” phase, immediate impacts are unlikely in daily clinical practice. However, the data collected could inform future medical device regulations and the adoption of immersive technologies in broader healthcare applications.
Regulatory context
Medical device trials, such as this, fall under stringent guidelines in compliance with national and international standards. Adherence to Medical Device Regulation (MDR) Annex XIV will govern the structuring and performance evaluation of GI Genius™ XR. Once data becomes available, regulatory agencies may review safety, usability, and clinical effectiveness before granting approvals for widespread clinical rollout.
FAQ
- What is the GI Genius™ XR software?
GI Genius™ XR utilizes AI and augmented visualization tools to assist clinicians in detecting abnormalities during colonoscopies. - Why is VR integrated into colonoscopy procedures?
Virtual reality allows for enhanced visualization, potentially streamlining procedures and improving diagnostic accuracy. - Is this software currently available for clinical use?
No. The software is under evaluation in a clinical trial phase. - What are the sponsors hoping to achieve?
Cosmo Artificial Intelligence-AI Ltd aims to demonstrate improved outcomes, procedural efficiency, and safe use of emerging technologies.
Conclusion
As the medical field embraces digital transformation, the ongoing trial for GI Genius™ XR highlights the innovative trends shaping routine procedures like colonoscopy. For clinical teams and regulatory professionals, this study could signal upcoming changes in medical device approvals and usage.
Disclaimer
The clinical trial information provided here is meant for professional audiences. It should not be construed as legal or financial advice.
Source announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07220174?term=medical+device