FDA OKs GE HealthCare’s MIM Contour ProtégéAI+ 2.0 for Radiation Therapy

GE HealthCare has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for MIM Contour ProtégéAI+ 2.0, an artificial intelligence (AI)-enabled auto-contouring software to assist with treatment planning in radiation oncology.

Manual contouring is a time-intensive step in radiation therapy planning. AI-based strategies can help make contouring more efficient while maintaining accuracy.

The underlying models for MIM Contour ProtégéAI+ were built and validated with multi-institution datasets. They’ve shown contour quality comparable to or exceeding traditional approaches, and GE HealthCare said they support consistent and reliable performance across clinical use cases.

The auto-contouring tool was designed to operate with minimal user interaction, unlike traditional tools. It begins contouring automatically and enables automated CT and MR image processing. Results can be exported into treatment planning systems or MIM Workflows to help reduce manual contouring effort and provide more time to focus on creating treatment plans.

“As radiation therapy continues to expand, there is a growing need to accelerate innovation to support the practice,” said Dr. Ben Newton, 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.”

The FDA nod includes a Predetermined Change Control Plan (PCCP), which forms a framework to introduce future model updates and enhancements. GE HealthCare said this will help expand models across other anatomical regions and imaging modalities.

“Our technology is designed with the realities of our customers in mind,” said J. Anders, General Manager, MIM, 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.”