GE HealthCare Receives FDA 510(k) Clearance for MIM Contour ProtégéAI+ 2.0 to Advance AI-Enabled Radiation Therapy Planning

GE HealthCare has received FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, an AI-enabled auto-contouring software designed to assist radiation oncology care teams with treatment planning. The clearance includes a Predetermined Change Control Plan, which establishes a framework for introducing future model updates and enhancements, helping enable the expansion of models across additional anatomical regions and imaging modalities.

Unlike traditional auto-contouring tools, MIM Contour ProtégéAI+ is designed to operate with minimal user interaction, initiating contouring automatically and helping enable automated processing of CT and MR images. Results can be exported directly into treatment planning systems, helping reduce manual contouring effort. GE HealthCare will showcase the software at the American Association of Medical Dosimetrists 51st Annual Meeting in Orlando, Florida.

Cancer continues to be a leading cause of death worldwide, accounting for nearly ten million deaths per year. Radiation therapy plays a central role in cancer care, used in nearly 60 percent of cases and for over 2 million patients in the United States annually. Manual contouring is one of the most time-intensive steps in radiation therapy planning, and AI-based approaches can help make contouring more efficient while maintaining accuracy. The underlying AI models for MIM Contour ProtégéAI+ were developed and validated using multi-institution datasets and have demonstrated contour quality comparable to or exceeding traditional approaches.

Dr. Ben Newton, Global Head of Oncology at GE HealthCare, said that as radiation therapy continues to expand, there is a growing need to accelerate innovation to support the practice. He noted that the introduction of MIM Contour ProtégéAI+ 2.0 represents an important step forward in advancing AI-enabled radiation therapy planning and that the FDA clearance of a Predetermined Change Control Plan allows the company to iterate more quickly, bringing new models and enhancements to customers to help enhance the treatment planning experience.

J. Anders, General Manager of MIM at GE HealthCare, said the technology is designed with the realities of customers in mind and that by automating one of the most time-intensive steps in radiation therapy planning, the software can help reduce treatment planning time and enable care teams to focus on refining treatment plans tailored to each patient’s needs.