FDA Clears Radformation's OptiPlan Automated VMAT Planning Module
核心洞察
Radformation (搜索) has received expanded FDA 510(k) clearance (K261718) for EZFluence (搜索) to include OptiPlan (搜索), its automated VMAT planning module, making it available for clinical use in the United States.
OptiPlan (搜索) generates high-quality VMAT plans from patient anatomy and clinical priorities defined through ClearCheck (搜索) templates, without requiring model training or commissioning.
The module was introduced earlier in Europe and Canada, and Radformation (搜索) will demonstrate it at the ASTRO 2026 Annual Meeting in Boston from September 27 to 29.
Radformation (搜索) has received expanded U.S. Food and Drug Administration 510(k) clearance (K261718) for EZFluence (搜索) to include OptiPlan (搜索), its automated volumetric modulated arc therapy (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 (搜索) is an optional module of EZFluence (搜索) and is not available in all markets, with availability subject to applicable regulatory approvals, the company said.
How the module works
OptiPlan (搜索) leverages patient anatomy and clinical priorities defined through ClearCheck (搜索) 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.
"OptiPlan (搜索) 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 (搜索). "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."
Demonstration at ASTRO 2026
OptiPlan (搜索) will be available for live demonstrations at the American Society for Radiation Oncology (ASTRO) Annual Meeting, held September 27 to 29 in Boston, Massachusetts. Attendees can test the automated VMAT planning workflow and review other Radformation (搜索) products across the radiotherapy workflow, including:
- An extended library of more than 520 AI-trained contouring models with AutoContour
- Reirradiation solutions with AutoContour and ClearCheck
- Zero-click plan and log file analysis with ClearCalc and RadMonteCarlo
- Automated offline adaptive assessment with ChartCheck Adaptive
- Automated billing QA and prior authorization review with QuickCode
Company footprint
Founded in 2016, Radformation (搜索) states that it serves more than 2,500 clinics worldwide in more than 60 countries, with a portfolio of products spanning the treatment planning workflow. The company describes its focus as increasing the safety and quality of cancer treatment by automating time-consuming tasks in radiation oncology.