GE HealthCare has received 510(k) clearance from the US Food and Drug Administration (FDA) for its medical imaging management (MIM) Contour ProtégéAI+ 2.0 software, an AI-powered auto-contouring tool designed to assist radiation oncology care teams in treatment planning.
The software aims to assist clinicians by automating manual contouring of anatomical structures using imaging data, which is one of the most resource-intensive parts of radiation therapy planning.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
By streamlining this process, the software is intended to help reduce the overall time needed for treatment planning and allow care teams to concentrate on creating more tailored treatment strategies.
FDA clearance for MIM Contour ProtégéAI+ 2.0 also includes a predetermined change control plan (PCCP).
According to GE HealthCare, the plan provides a framework for future software updates and enhancements, potentially expanding support to additional anatomical regions and imaging modalities.
GE HealthCare oncology global head Dr Ben Newton said: “As radiation therapy continues to expand, there is a growing need to accelerate innovation to support the practice. The introduction of MIM Contour ProtégéAI+ 2.0 represents an important step forward in advancing AI-enabled radiation therapy planning.
“The FDA clearance of a predetermined change control plan allows us to iterate more quickly, bringing new models and enhancements to our customers to help enhance the treatment planning experience.”
GE HealthCare stated that the AI models powering the software were developed and validated using datasets from multiple institutions and have shown contour quality that matches or surpasses traditional methods, supporting reliability in clinical use.
Unlike some auto-contouring tools that require substantial user input, MIM Contour ProtégéAI+ 2.0 is designed to automatically initiate the contouring process, supporting analysis of computed tomography and magnetic resonance images.
Results from the software can be exported directly to treatment planning systems or via MIM Workflows.
GE HealthCare MIM general manager J Anders said: “By automating one of the most time-intensive steps in radiation therapy planning, MIM Contour ProtégéAI+ 2.0 can help reduce treatment planning time and enable care teams to focus on refining treatment plans tailored to each patient’s needs.”
The software forms part of the wider MIM portfolio within GE HealthCare’s radiation oncology ecosystem and is designed for integration into existing clinical workflows.
In April, GE HealthCare expanded its partnership with RadNet subsidiary DeepHealth to broaden access to AI-powered breast cancer screening solutions.
