GE HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Contour ProtégéAI+ 2.0 medical image management (MIM) software, an AI-powered automated contouring tool designed to assist radiology teams with treatment planning.
The software aims to assist physicians by automating the manual contouring of anatomical structures using image data, which is one of the most resource-intensive parts of radiation therapy planning.
By streamlining this process, the software aims to help reduce the overall time required for treatment planning and allow medical teams to focus on creating more personalized treatment strategies.
The FDA clearance for MIM Contour ProtégéAI+ 2.0 also includes a pre-defined change control plan (PCCP).
According to GE HealthCare, this plan lays the foundation for future software updates and enhancements, potentially expanding support for additional anatomical regions and imaging modalities.
Dr. Ben Newton, Head of Global Oncology at GE HealthCare, stated, "As the use of radiation therapy expands, there is a growing need to accelerate innovation to support this practice. The introduction of MIM Contour ProtégéAI+ 2.0 represents a significant step forward in the development of AI-powered radiation therapy planning.".
«"Receiving FDA approval of a pre-developed change management plan allows us to more quickly implement new models and improvements for our customers to improve the treatment planning process.".
GE HealthCare said the artificial intelligence models underlying the software were developed and validated using datasets from multiple institutions and demonstrated contour quality that meets or exceeds traditional methods, confirming reliability in clinical use.
Unlike some automatic contouring tools that require significant user interaction, MIM Contour ProtégéAI+ 2.0 is designed to automatically initiate the contouring process, supporting CT and MRI image analysis.
Results obtained using the software can be exported directly to treatment planning systems or via MIM workflows.
GE HealthCare MIM General Manager J. Anders stated, «By automating one of the most time-consuming steps in radiation therapy planning, MIM Contour ProtégéAI+ 2.0 can help reduce treatment planning time and allow medical teams to focus on refining treatment plans tailored to the needs of each patient.».
This software is part of the broader MIM portfolio within the GE HealthCare radiation therapy ecosystem and is designed to integrate into existing clinical workflows.
In April, GE HealthCare expanded its partnership with RadNet subsidiary DeepHealth to expand access to AI-powered breast cancer screening solutions.
The article "FDA Approves GE HealthCare's MIM Contour ProtégéAI+ 2.0 Software" was originally created and published by Hospital Management, a brand owned by GlobalData.
The information on this website is provided in good faith and is for general informational purposes only. It is not intended to constitute advice on which you should rely, and we make no representations, warranties, or promises, express or implied, regarding its accuracy or completeness. Before making or refraining from making any decisions based on the information provided on our website, you should seek professional or specialized advice.