GEHC nets FDA clearance for MIM Contour ProtégéAI+ 2.0

GE HealthCare (GEHC) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MIM Contour ProtégéAI+ 2.0, an AI-enabled autocontouring software for radiation therapy treatment planning.

The software is designed to initiate contouring automatically with minimal user interaction, processing CT and MR images and exporting results directly into treatment planning systems. The underlying AI models were developed and validated using multi-institution datasets and have demonstrated contour quality comparable to or exceeding traditional approaches, GEHC said.

The clearance includes a Predetermined Change Control Plan (PCCP), which establishes a framework for introducing future model updates across additional anatomical regions and imaging modalities without requiring a separate clearance for each update. The software is part of GEHC's MIM portfolio within its radiation oncology ecosystem.