GE HealthCare announced on June 4 that the U.S. Food and Drug Administration has cleared MIM Contour ProtégéAI+ 2.0, an AI-powered auto-contouring software designed to assist radiation oncology teams in treatment planning. The 510(k) clearance includes a Predetermined Change Control Plan (PCCP) — a framework that lets GE HealthCare iterate the underlying AI models without going back through full submissions for every update.
Automating the most time-intensive step in radiation planning
The software automates manual contouring of anatomical structures on imaging data — one of the most resource-intensive parts of radiation therapy planning. By starting the contouring process automatically on CT and MR studies, the tool is intended to cut planning time and let care teams focus on patient-specific treatment refinement. Results export directly to treatment planning systems or via MIM Workflows, keeping the AI inside the existing oncology workflow rather than forcing a new tool stack.
New MR brain model, expanded male pelvis CT model
Version 2.0 adds a Magnetic Resonance Brain model and an updated computed tomography Male Pelvis model, expanding clinical coverage to key anatomical regions. GE HealthCare's oncology global head Dr. Ben Newton said the PCCP "allows us to iterate more quickly, bringing new models and enhancements to our customers," while MIM general manager J Anders argued the tool lets teams "focus on refining treatment plans tailored to each patient's needs." The company says the underlying AI models were trained and validated on multi-institution datasets and have shown contour quality matching or surpassing traditional methods.
Part of a broader GE HealthCare AI push
The MIM Contour ProtégéAI+ 2.0 clearance follows GE HealthCare's April expansion of its partnership with RadNet subsidiary DeepHealth to broaden access to AI-powered breast cancer screening solutions, and it slots into the company's broader radiation oncology ecosystem. The PCCP pathway, in particular, sets a regulatory template that other clinical AI vendors are likely to follow as the FDA pushes for more iterative AI device oversight.
The approval drops alongside a wave of recent clinical AI news, including Compal and PolyMedX's NVIDIA-powered smart hospital platform, SSi Mantra's 12,500-mile robotic telesurgery and the Birmingham low-temperature hydrogen catalyst.
Reporting based on coverage from Medical Device Network, ITN Online, Investing.com, Yahoo Finance and BioSpace.