MR DWI/FLAIR Measurement V1.0
Olea MedicalMR DWI/FLAIR Measurement V1.0 is a medical image processing software developed by Olea Medical that analyzes MRI brain images from diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR) sequences. It automatically computes diffusion maps and extracts relevant metrics to assist medical professionals in evaluating brain conditions. The software integrates with existing medical imaging platforms and helps clinicians by providing quantitative analysis to complement their diagnosis and treatment planning.
Intended Use
MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of MR Diffusion-weighted imaging (DWI) and MR FLAIR images to assist clinicians in medical imaging assessment workflow by computing ADC maps and extracting relevant metrics.
Technology
The software uses a deep learning-based diffusion brain extraction tool (BET) to preprocess MR DWI images by filtering noise and excluding background pixels before computing ADC maps and normalized FLAIR maps. It runs as a standalone Docker application integrated on a compatible technical platform for DICOM image input/output handling and visualization.
Performance
The device was validated with extensive software verification and clinical comparative image studies, showing excellent segmentation accuracy (Dice score 0.816 to 0.976) and close agreement in relative and normalized FLAIR map calculations with the predicate device, demonstrating equivalence in safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/28/2023
1 month - 2
FDA Approval
4/26/2023
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