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GE HealthCare receives FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, advancing AI-enabled radiation therapy planning with expanded clinical capabilities

GEHC
  • GE HealthCare received FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, an AI-enabled auto-contouring software for radiation oncology treatment planning.
  • The software introduces new models, including an MR Brain model, & an updated CT Male Pelvis model, expanding capabilities across key anatomical regions.
  • Clearance includes a Predetermined Change Control Plan (PCCP) framework to facilitate future model updates & enhancements across additional imaging modalities.
  • MIM Contour ProtégéAI+ 2.0 operates with minimal user interaction to automate CT & MR image contouring, aiming to reduce treatment planning time.
  • AI models were developed & validated using multi-institution datasets, demonstrating contour quality comparable to or exceeding traditional approaches.
  • GE HealthCare will showcase the software at booth #202 during the American Association of Medical Dosimetrists 51st Annual Meeting in Orlando, Florida, from June 7-10, 2026.
  • Dr. Ben Newton of GE HealthCare stated the PCCP allows for faster iteration & delivery of new models to support the evolving needs of radiation therapy.
  • The software integrates seamlessly into existing clinical workflows & exports results directly into treatment planning systems or MIM Workflows™.