The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to GE HealthCare’s MIM Contour ProtégéAI+ 2.0, an AI-enabled auto-contouring software designed to assist radiation oncologists with treatment planning. AI-driven auto-contouring can significantly reduce the workload of radiation oncology care teams.  

“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,” stated J. Anders, General Manager of MIM, GE HealthCare.  

The company also announced the introduction of a new model for brain magnetic resonance imaging (MRI) and an updated model for male pelvic computed tomography (CT).  

The FDA clearance includes a Predetermined Change Control Plan, which establishes a framework for future updates to the model without requiring additional regulatory reviews. According to the company, the plan will also support expansion of the model to other imaging modalities and anatomical regions.  

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

Contour ProtégéAI+ 2.0 uses a neural network framework based on the U-Net encoder-decoder architecture for image segmentation, along with multiple weighted layers.  

The model was trained on a large, multi-institutional data set and validated using a separate large data set. Performance was evaluated using several metrics, including the dice coefficient, mean distance to agreement, qualitative user feedback scores, localization success, and added path length compared with ground-truth contours.  

Contour ProtégéAI+ 2.0 is part of GE HealthCare’s MIM portfolio of imaging technologies and workflow solutions and is designed to integrate into existing workflows. The software supports autonomous operation and automated processing of MRI and CT images. Auto-contouring results can be exported to treatment planning systems or the MIM Workflows platform. 

ASCO AI in Oncology is published by Conexiant under a license arrangement with the American Society of Clinical Oncology, Inc. (ASCO^®). The ideas and opinions expressed in ASCO AI in Oncology do not necessarily reflect those of Conexiant or ASCO. For more information, see Policies.