MIM – Symphony HDR Fusion
MIM Software Inc.MIM – Symphony HDR Fusion is an advanced medical imaging software designed to assist trained clinicians with processing and analyzing multiple imaging modalities such as CT, MRI, PET, and ultrasound. It supports fusion and registration of images, contouring of tumors and tissues, and planning for high dose rate brachytherapy treatments. By integrating image visualization, catheter digitization, and dose planning, it helps clinicians optimize radiation therapy for cancer patients safely and effectively.
Intended Use
MIM software is intended for trained medical professionals to manage digital medical images by receiving, storing, displaying, registering, fusing, and processing images from multiple modalities for diagnosis, treatment evaluation, and planning including brachytherapy and ablation procedures.
Technology
MIM – Symphony HDR Fusion is standalone software available on Windows, Mac, and Linux. It extends the existing MIM Monte Carlo Dosimetry software functionality to support High Dose Rate brachytherapy workflows by enabling fusion of 2D TRUS ultrasound images with pre-op MR images, catheter digitization, sequential image registration, and export to third-party treatment planning systems.
Performance
Verification and validation testing was performed on the five core features including reslicing and predictive fusion, ultrasound capture, catheter digitization, registration chaining, and data export. Testing included internal verification and external validation by experienced HDR brachytherapy professionals. All features met acceptance criteria, demonstrating safe and effective clinical use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
26 days - 2
FDA Approval
10/23/2024
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