GE HealthCare receives FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, advancing AI-enabled radiation therapy planning with expanded clinical capabilities

Key Terms

510(k) clearance regulatory

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

predetermined change control plan regulatory

A predetermined change control plan is a pre-approved roadmap that lists likely future changes to a product’s manufacturing, testing, or labeling and explains how those changes will be evaluated and controlled without needing fresh regulatory approval each time. Think of it like a recipe that allows certain safe ingredient swaps and cooking tweaks already signed off by a reviewer; for investors it reduces delay and uncertainty around production updates, quality issues, and cost management, which can speed product availability and lower regulatory risk.

magnetic resonance (mr) medical

Magnetic resonance (MR) is a medical imaging technique that uses strong magnetic fields and radio waves to create detailed pictures of structures inside the body, similar to using a camera that can see organs and tissues without surgery. Investors care because MR technology, machines, and related services drive revenue in hospitals, diagnostics, and clinical trials, and changes in approval, reimbursement, or usage rates can affect the financial performance of manufacturers and healthcare providers.

computed tomography (ct) medical

Computed tomography (CT) is a medical imaging technique that uses X-ray technology to create detailed cross-sectional pictures of the inside of the body, similar to taking multiple slices of a loaf of bread to see its internal structure. For investors, understanding CT is important because it represents advanced technology that can improve diagnostics and healthcare efficiency, potentially influencing the performance of companies involved in medical imaging and health services.

radiation therapy medical

Radiation therapy uses focused high-energy rays or particles to kill or shrink abnormal cells inside the body, often delivered from outside the body or by placing tiny sources near the target. Think of it like using a magnifying glass to concentrate sunlight on a small spot to remove a weed without digging up the whole garden. Investors watch radiation therapy because its effectiveness, side effects, regulatory approvals, equipment needs and reimbursement rules directly affect healthcare companies’ revenues, clinical trial outcomes and long-term costs.

radiation oncology medical

Radiation oncology is the medical specialty that uses carefully controlled beams of radiation to shrink or destroy tumors, much like using a focused heat lamp or precise scissors to remove a problem area without cutting away healthy tissue. For investors, it matters because demand for radiation oncology drives sales of expensive machines, software, treatment services and related drugs, and is influenced by regulation, reimbursement and technological advances that can change profit potential across equipment makers, hospitals and service providers.

auto-contouring medical

Auto-contouring is software that automatically traces and labels organs, tumors or other structures on medical images so clinicians can plan treatments like radiation more quickly and consistently. For investors, it matters because faster, more reliable contouring can cut clinical time and costs, reduce variation in care, and increase demand for imaging and therapy products or services—affecting revenue, regulatory review and adoption of related medical technologies.

imaging modalities medical

Different technological methods used to create pictures of the inside of the body—such as MRI, CT, X‑ray, ultrasound or PET—each work like a different type of camera for specific medical tasks. Investors care because which modality is chosen affects a device or drug’s market size, regulatory hurdles, pricing and how quickly doctors adopt it; a product that fits a widely used modality or improves diagnostic accuracy can drive revenue and competitive advantage.

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• Marking the evolution of MIM AI-enabled auto-contouring software, MIM Contour ProtégéAI+ 2.0 introduces new models, including a Magnetic Resonance (MR) Brain model, as well as an updated Computed Tomography (CT) Male Pelvis model, expanding clinical capabilities across key anatomical regions.
• GE HealthCare will showcase MIM Contour ProtégéAI+ 2.0 at booth #202 during the American Association of Medical Dosimetrists 51^st Annual Meeting taking place June 7-10, 2026 in Orlando, Florida.

CHICAGO--(BUSINESS WIRE)-- GE HealthCare (Nasdaq: GEHC) today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for MIM Contour ProtégéAI+™ 2.0, an AI-enabled auto-contouring software to assist radiation oncology care teams with treatment planning. This can help clinicians reduce treatment planning time, enabling them to focus on delivering more timely and personalized care for patients.

The FDA clearance includes a Predetermined Change Control Plan (PCCP), which establishes a framework for introducing future model updates and enhancements. This will help enable the expansion of models across additional anatomical regions and imaging modalities.

According to the World Health Organization, cancer continues to be a leading cause of death worldwide, accounting for nearly ten million deaths per year.ⁱ Earlier detection and treatment could help reduce a meaningful portion of this burden. Radiation therapy plays a central role in cancer care, used in nearly 60% of cases and for over 2 million U.S. patients annually.^ii,iii The radiation therapy field continues to evolve to meet increasingly complex patient needs, with emerging technologies helping clinicians deliver more precise, efficient care.

“As radiation therapy continues to expand, there is a growing need to accelerate innovation to support the practice,” said Dr. Ben Newton, Global Head of Oncology at GE HealthCare. “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.”

Manual contouring is one of the most time-intensive steps in radiation therapy planning. AI-based approaches can help make contouring more efficient while maintaining accuracy. The underlying AI models for MIM Contour ProtégéAI+ were developed and validated using multi-institution datasets and have demonstrated contour quality comparable to, or exceeding, traditional approaches, supporting consistent and reliable performance across clinical use cases.^iv

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 or MIM Workflows™, helping reduce manual contouring effort and providing care teams more time to focus on creating treatment plans for their patients.

“Our technology is designed with the realities of our customers in mind,” said J. Anders, General Manager, MIM, GE HealthCare. “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.”

The software is part of the MIM portfolio within GE HealthCare’s radiation oncology ecosystem and is designed to integrate seamlessly into existing clinical workflows. Learn more about MIM Contour ProtégéAI+ 2.0 and other MIM software solutions at the booth (#202) at the American Association of Medical Dosimetrists 51^st Annual Meeting or visit online at gehealthcare.com.

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global healthcare solutions provider of advanced medical technology, pharmaceutical diagnostics, and AI, cloud and software solutions that help clinicians tackle the world’s most complex diseases. Serving patients and providers for 130 years, GE HealthCare is delivering bold innovations designed for the next era of medicine across its Advanced Imaging Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics segments to help clinicians deliver more personalized, precise patient care. We are a $20.6 billion business with approximately 54,000 colleagues working to create a world where healthcare has no limits.

GE HealthCare is proud to be among 2026 Fortune World’s Most Admired Companies™.

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ⁱ World Health Organization, Cancer, 2025, https://www.who.int/news-room/fact-sheets/detail/cancer.

ⁱⁱ American Society for Radiation Oncology. Radiation Oncology Case Rate (ROCR) Report. June 26, 2023. https://www.astro.org/ASTRO/media/ASTRO/Advocacy/PDFs/ROCRReport.pdf

ⁱⁱⁱ American Society for Radiation Oncology (ASTRO). “Geographic Access to Radiation Therapy in the United States.” ASTRO Press Kit, 2020.

^iv Wan, Hanlin, and Soroush Heidari Pahlavian. Automated Contouring Using Neural Networks. White paper, MIM Software Inc., September 24, 2025.

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GE HealthCare Media Contact:
Kim Schmohl
M +1 929 289 1937
kimberly.schmohl@gehealthcare.com

Source: GE HealthCare