GE HealthCare receives FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, advancing AI-enabled radiation therapy planning with expanded clinical capabilities
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Marking the evolution of
MIM AI -enabled auto-contouring software, MIM Contour ProtégéAI+ 2.0 introduces new models, including a Magnetic Resonance (MR) Brain model, as well as an updated Computed Tomography (CT) Male Pelvis model, expanding clinical capabilities across key anatomical regions. -
GE HealthCare will showcase MIM Contour ProtégéAI+ 2.0 at booth #202 during theAmerican Association of Medical Dosimetrists 51st Annual Meeting taking placeJune 7-10, 2026 inOrlando, Florida .
The FDA clearance includes a Predetermined Change Control Plan (PCCP), which establishes a framework for introducing future model updates and enhancements. This will help enable the expansion of models across additional anatomical regions and imaging modalities.
According to the
“As radiation therapy continues to expand, there is a growing need to accelerate innovation to support the practice,” said Dr.
Manual contouring is one of the most time-intensive steps in radiation therapy planning. 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, supporting consistent and reliable performance across clinical use cases.iv
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 or MIM Workflows™, helping reduce manual contouring effort and providing care teams more time to focus on creating treatment plans for their patients.
“Our technology is designed with the realities of our customers in mind,” said
The software is part of the MIM portfolio within GE HealthCare’s radiation oncology ecosystem and is designed to integrate seamlessly into existing clinical workflows. Learn more about MIM Contour ProtégéAI+ 2.0 and other MIM software solutions at the booth (#202) at the
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i World Health Organization, Cancer, 2025, https://www.who.int/news-room/fact-sheets/detail/cancer.
ii American Society for Radiation Oncology. Radiation Oncology Case Rate (ROCR) Report. June 26, 2023. https://www.astro.org/ASTRO/media/ASTRO/Advocacy/PDFs/ROCRReport.pdf
iii American Society for Radiation Oncology (ASTRO). “Geographic Access to Radiation Therapy in the United States.” ASTRO Press Kit, 2020.
iv Wan, Hanlin, and Soroush Heidari Pahlavian. Automated Contouring Using Neural Networks. White paper, MIM Software Inc., September 24, 2025.
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GE HealthCare Media Contact:
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kimberly.schmohl@gehealthcare.com
Source: GE HealthCare