ART-Plan+ (v3.0.0) is an AI-based software platform designed to assist cancer treatment via radiotherapy. It automatically segments organs at risk, lymph nodes, and tumors on CT and MR images and generates radiotherapy treatment plans. These plans are imported into clinicians' Treatment Planning Systems for dose calculation, review, and approval, helping streamline and improve the radiotherapy planning process for trained medical professionals.
Software platform indicated for cancer patients prescribed radiotherapy treatment, providing AI-based segmentation of organs at risk, lymph nodes, tumors and automatic radiotherapy treatment plan generation imported into local TPS systems for dose calculation and approval.
AI-based deep learning segmentation for multiple anatomical regions on CT and MR images; automatic treatment plan generation imported into external TPS; supports batch processing integration into radiotherapy workflow.
Extensive non-clinical validation for auto-segmentation and treatment planning including comparison to manual contours by experts using DSC metrics, qualitative clinician assessments, inter-expert variability checks, and quantitative validation on multiple patient datasets; acceptance criteria consistently met for clinical use; treatment plans evaluated quantitatively and qualitatively with high clinical acceptability rates.
No predicate devices specified
Submission
9/18/2024
FDA Approval
2/25/2025
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