Neurophet AQUA AD Plus
Neurophet., Inc.Neurophet AQUA AD Plus is an AI-powered software that assists clinicians by automatically labeling and quantifying brain structures and lesions using MRI and PET scans. It also calculates standardized uptake value ratios (SUVR) to help evaluate neurodegenerative conditions, streamlining image analysis and enhancing clinical workflow.
Intended Use
Neurophet AQUA AD Plus is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions, as well as SUVR quantification from a set of MR and PET images. Volumetric measurements may be compared to reference percentile data.
Technology
The device is a software system applying AI modules for automated segmentation and quantitative analysis of brain structures and lesions on MR and PET images. It uses deep learning technologies and compares volumetric results to normative reference data, generating standardized uptake value ratios (SUVR) and Centiloid scales to quantify amyloid accumulation and dementia severity. It operates on standard hardware and supports DICOM image formats.
Performance
Performance testing used independent multi-center MRI and PET datasets diverse in vendors, protocols, demographics, and clinical conditions. AI modules achieved high Dice Similarity Coefficients (around 0.83-0.90) for segmentation accuracy and excellent agreement (ICC >= 0.993) with FDA-cleared predicate devices for SUVR quantification. Centiloid-based amyloid classification showed substantial agreement with expert reads. Validation covered multiple MRI sequences and PET tracers with quality controls ensuring robust and reproducible results across diverse populations.
Predicate Devices
No predicate devices specified
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