Radformation Receives USFDA 510(k) Clearance for OptiPlan Automated VMAT Planning

NEW YORK--(BUSINESS WIRE)--Radformation, a leading provider of intelligent automation solutions for radiation oncology, today announced the expanded U.S. Food and Drug Administration (FDA) 510(k) clearance (K261718) for EZFluence to include OptiPlan*, its new 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.

See OptiPlan at ASTRO 2026
OptiPlan will be available for live demonstrations at the American Society for Radiation Oncology (ASTRO) Annual Meeting September 27th-29th in Boston, MA. Attendees can experience OptiPlan automated VMAT planning firsthand and explore Radformation’s latest advancements across the radiotherapy workflow, including:

• An extended library of 520+ AI-trained contouring models with AutoContour
• Enhanced reirradiation solutions with AutoContour and ClearCheck
• Zero-Click plan and log file analysis with ClearCalc and RadMonteCarlo
• Fully automated offline adaptive assessment with ChartCheck Adaptive
• Automated billing QA and prior authorization review with QuickCode

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

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

About Radformation

Radformation is committed to improving the lives of clinicians by delivering user-friendly products developed to increase the safety and quality of cancer treatment. Radformation envisions a radiation oncology clinic where staff are equipped with solutions that supplement their expertise and automate time-consuming tasks, leading to better patient care everywhere. Since its founding in 2016, Radformation has grown to serve over 2,500 clinics worldwide in more than 60 countries, with a portfolio of products that accelerates every stage of the treatment planning workflow. For more information, visit radformation.com.