Intended Use

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.

Technology

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.

Performance

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.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/18/2024

    5 months
  • 2

    FDA Approval

    2/25/2025

Other devices from Therapanacea SAS

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