Neurophet AQUA
NEUROPHET, Inc.Neurophet AQUA is a software tool that helps clinicians and researchers analyze brain MRI scans by automatically identifying and measuring brain structures. It generates detailed reports comparing patient brain volumes to reference data, aiding in the assessment of neurological conditions and monitoring structural brain changes.
Intended Use
Neurophet AQUA is intended for Automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. Volumetric data may be compared to reference percentile data.
Technology
Neurophet AQUA is a fully automated MR imaging post-processing software that automatically segments, calculates volumes, and generates morphometric reports of brain structures from T1-weighted MRI scans using a proprietary internal pipeline with deep learning for segmentation.
Performance
Performance was validated via software verification, segmentation accuracy comparison with expert manual segmentations yielding Dice coefficients of 75-90%, and reproducibility tests on repeated scans showing low volume differences (1-5%). Training used 300 MRIs from various scanners and included cognitive normal and disease states to ensure robustness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/16/2022
1 year, 2 months - 2
FDA Approval
5/10/2023
Other devices from NEUROPHET, Inc.
- Neurophet AQUA (V3.1)2024 • 510K
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