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Intended Use

Neurophet AQUA is intended for Automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions 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 medical device software. It uses a proprietary automated internal pipeline performing segmentation, volume calculation, lesion quantification, and report generation. It processes T1 MRI data and additionally analyzes T2 FLAIR MRI images for lesion detection. Outputs include segmented color overlays and morphometric reports that compare to age and gender-matched reference data, displayed via a dedicated graphical user interface and PACS compatibility. It incorporates automated quality control functions like scan protocol verification.

Performance

The device underwent software verification/validation testing confirming functionality and reliability. Its deep learning lesion segmentation algorithm was validated with multi-site, diverse clinical datasets, compared against expert neuroradiologist consensus, achieving Dice coefficient >0.80 for lesion segmentation accuracy and high reproducibility (mean absolute lesion volume difference <0.25cc). The T1 image segmentation performance was previously validated under prior clearance K220437.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    7/29/2024

    2 months
  • 2

    FDA Approval

    10/25/2024

Other devices from Neurophet, Inc.

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