News | Radiation Oncology | September 21, 2026

Radformation has received FDA 510(k) clearance for its OptiPlan Automated VMAT Planning.

Automated VMAT Planning Receives FDA Clearance

Sept.21, 2026 — Radformation, a provider of intelligent automation solutions for radiation oncology, has expanded U.S. Food and Drug Administration (FDA) 510(k) clearance (K261718) for EZFluence to include OptiPlan*, its automated VMAT planning module. The clearance makes OptiPlan available for clinical use in the United States, expanding access following its introduction in Europe and Canada. 

“OptiPlan was built in direct response to what we were hearing from our users. Treatment planners need ways to work more efficiently without giving up control over clinical decisions,” said Jayne Churness, Director of Product Management at Radformation. “By automating repetitive optimization work while keeping clinicians at the center of the process, OptiPlan gives planners more time to focus on the decisions where their expertise matters most.” 

OptiPlan leverages patient anatomy and clinical priorities defined through ClearCheck templates to generate high-quality VMAT plans without model training or commissioning. Planners can refine the balance between target coverage and organ-at-risk sparing by comparing plan options side by side before selecting the approach that best meets the patient’s clinical objectives.

More information about OptiPlan can be found at radformation.com/optiplan/optiplan.

 

*OptiPlan automated VMAT planning is an optional module of EZFluence and is not available in all markets. Availability is subject to applicable regulatory approvals.

 

Radformatiom FDA

 


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