NeuroQuant
CorTechs Labs, Inc.NeuroQuant is an automated software device designed to help clinicians by providing automatic labeling, visualization, and volumetric measurement of brain structures and lesions from MRI scans. It enhances clinical workflow by delivering segmented images and morphometric reports that can be reviewed and compared to normative data, aiding in diagnosis and monitoring of neurological conditions.
Intended Use
NeuroQuant is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric measurements may be compared to reference percentile data.
Technology
NeuroQuant is a fully automated MR imaging post-processing software that uses probabilistic methods and neural network models for anatomical labeling and volumetric quantification. It processes various MR sequences, corrects for scanner artifacts and intensity variability, supports DICOM input and outputs volumetric data and segmented images in standard formats. It includes deep-learning models for brain segmentation, FLAIR lesion segmentation, and microbleed detection.
Performance
Performance testing included verification and validation of three deep-learning models: brain segmentation, FLAIR lesion segmentation, and microbleed detection. Metrics such as Dice Similarity Coefficient and F1 Score demonstrated accuracy, robustness, and generalizability on diverse datasets. Testing confirmed substantial equivalence to predicate and compliance with FDA guidance and standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/22/2024
4 months - 2
FDA Approval
8/22/2024
Other devices from CorTechs Labs, Inc.
- OnQ Neuro2021 • 510K
- NeuroQuant2017 • 510K
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