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.

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