CHICAGO — GE HealthCare has received U.S. Food and Drug Administration 510(k) clearance for MIM Contour ProtégéAI+ 2.0, an AI-enabled auto-contouring software designed to support radiation oncology treatment planning.
The Chicago-based medical technology company said the software can help radiation oncology teams reduce treatment planning time by automating part of the contouring process, one of the more time-intensive steps in radiation therapy planning.
MIM Contour ProtégéAI+ 2.0 expands the capabilities of GE HealthCare’s AI-enabled auto-contouring platform with new and updated models, including a magnetic resonance brain model and an updated computed tomography male pelvis model.
The FDA clearance also includes a Predetermined Change Control Plan, which creates a framework for future model updates and enhancements. GE HealthCare said the plan is expected to support the expansion of models across additional anatomical regions and imaging modalities.
“As radiation therapy continues to expand, there is a growing need to accelerate innovation to support the practice,” said Ben Newton, M.D., global head of oncology at GE HealthCare. “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.”
Radiation therapy is used in nearly 60% of cancer cases and in more than 2 million U.S. patients annually, according to figures cited by GE HealthCare. The company said AI-based contouring tools can help improve efficiency while maintaining accuracy as radiation oncology teams manage increasingly complex patient needs.
The AI models underlying MIM Contour ProtégéAI+ were developed and validated using multi-institution datasets, according to GE HealthCare. The company said the models demonstrated contour quality comparable to, or exceeding, traditional approaches across clinical use cases.
MIM Contour ProtégéAI+ is designed to operate with minimal user interaction, automatically initiating contouring and supporting automated processing of CT and MR images. Results can be exported into treatment planning systems or MIM Workflows.
“Our technology is designed with the realities of our customers in mind,” said J. Anders, general manager of MIM at GE HealthCare. “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.”
GE HealthCare said it will showcase MIM Contour ProtégéAI+ 2.0 during the American Association of Medical Dosimetrists 51st Annual Meeting, scheduled for June 7-10 in Orlando, Florida.
