GE HealthCare receives FDA clearance

GE HealthCare received 510(k) clearance from the United States United States — Food and Drug Administration for MIM Contour ProtégéAI+ 2.0, an AI-enabled auto-contouring software designed to assist radiation oncology care teams with treatment planning. This software introduces new models, including an MR Brain model and an updated CT Male Pelvis model, expanding its clinical capabilities. The clearance includes a Predetermined Change Control Plan, allowing for future model updates without separate clearances. This technology aims to make manual contouring, a time-intensive step in radiation therapy, more efficient and accurate, ultimately reducing treatment planning time and enabling clinicians to focus on personalized patient care. The software is part of GE HealthCare's MIM portfolio and integrates into existing clinical workflows. Dr. Jan Newton and Anderson of GE HealthCare highlighted the significance of this advancement for radiation therapy.