BrainSee
Darmiyan, Inc.BrainSee is software that helps clinicians predict whether patients aged 55 to 95 with amnestic mild cognitive impairment (aMCI) will progress to clinical Alzheimer's disease dementia within 5 years. It uses standard brain MRI scans along with patient demographics and cognitive test scores to generate a similarity score indicating the likelihood of progression. This tool provides supplemental prognostic information to aid clinical decision-making but is not a standalone diagnostic device.
Intended Use
BrainSee is indicated as a prognostic tool to aid clinicians in assessing the likelihood that patients aged 55-95 diagnosed with amnestic mild cognitive impairment will progress to clinical Alzheimer's disease dementia within 5 years. It analyzes brain MRI, demographic, and cognitive assessment data to produce a similarity score reflecting resemblance to patients who converted or did not convert to dementia.
Technology
BrainSee is a cloud-based software as a medical device (SaMD) that processes standard 3D T1-weighted brain MRI scans acquired at 1.5T or 3T, along with cognitive test scores (e.g., MMSE, CDR), age, and sex to compute tissue volumes and generate a similarity score reflective of disease progression risk. Software validation and hazard analysis were conducted to ensure safety and accuracy. The platform allows clinicians to upload scans and input data via a web portal to obtain prognostic results.
Performance
A retrospective clinical validation study was conducted on 198 patients diagnosed with aMCI from 27 North American sites. BrainSee demonstrated 96% specificity, 73% sensitivity, 97% positive predictive value, and 71% negative predictive value in predicting progression to Alzheimer's dementia within 5 years. Limitations include under-representation of certain demographics, to be addressed in ongoing postmarket studies. Usability testing showed most clinicians could operate the software and interpret outputs effectively.
Device Timeline
- 1
Submission
9/29/2022
1 year, 3 months - 2
FDA Approval
1/11/2024
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