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Home » GE HealthCare earns FDA nod for AI-enabled radiotherapy tech

GE HealthCare earns FDA nod for AI-enabled radiotherapy tech

June 4, 2026 By Sean Whooley

GE HealthCare LogoGE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its MIM Contour ProtégéAI+ 2.0 software.

Chicago-based GE HealthCare designed its AI-enabled auto-contouring software to assist radiation oncology teams with treatment planning. It aims to reduce treatment planning time, enabling more focus on delivering timely, personalized care.

FDA clearance includes a Predetermined Change Control Plan (PCCP) as well, the company said in a news release. This establishes a framework for introducing future model updates and enhancements. GE HealthCare expects this to help enable the expansion of models across additional anatomical regions and imaging modalities.

According to GE HealthCare, AI-based approaches can help make contouring, a time-sensitive step in radiation therapy planning, more efficient while maintaining accuracy.

Unlike traditional auto-contouring tools, MIM Contour ProtégéAI+ 2.0 operates with minimal user interaction. It initiates contouring automatically and helps to enable automated processing of CT and MR images. Results can export directly into treatment planning systems or MIM workflows.

The new offering adds to GE HealthCare’s MIM Software portfolio of solutions for radiation oncology. The company brought the software into its portfolio through an acquisition of MIM Software in April. It introduced a new MIM solution for prostate care in 2024.

Commentary from GE HealthCare officials

Dr. Ben Newton, global head of Oncology at GE HealthCare, said:

“As radiation therapy continues to expand, there is a growing need to accelerate innovation to support the practice. The introduction of MIM Contour ProtégéAI+ 2.0 represents an important step forward in advancing AI-enabled radiation therapy planning. The FDA clearance of a Predetermined Change Control Plan allows us to iterate more quickly, bringing new models and enhancements to our customers to help enhance the treatment planning experience.”

J. Anders, GM, MIM, GE HealthCare, added:

“Our technology is designed with the realities of our customers in mind. By automating one of the most time-intensive steps in radiation therapy planning, MIM Contour ProtégéAI+ 2.0 can help reduce treatment planning time and enable care teams to focus on refining treatment plans tailored to each patient’s needs.”

Filed Under: 510(k), Artificial Intelligence (AI), Food & Drug Administration (FDA), Health Technology, Imaging, Radiosurgery/Radiation therapy, Regulatory/Compliance, Software / IT Tagged With: FDA, GE Healthcare

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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