BrainSee foresaw which memory patients would develop dementia

In FDA's review, BrainSee predicted which of 198 patients with amnestic mild cognitive impairment developed Alzheimer's dementia within five years, with 96% specificity and 73% sensitivity.

  • Not rated an organization

    The predictions were made on archived records, and no clinician acted on the scores.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Pre-defined goals of sensitivity and specificity above 70%. Measured.

Without the system
Goals above 70%
With it
Specificity 96%, sensitivity 73% with a lower bound of 65%
The system’s part
Not isolated. The study measured accuracy against later clinical diagnoses and did not compare care with and without the score. FDA describes a model trained on patients who did and did not progress but does not name the method.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Task Accuracy
System
BrainSee
Made by
Darmiyan, Inc.
Used by
Darmiyan (retrospective validation on 198 patients from 27 North American sites)
Where
27 North American sites
Stage
Tested in a laboratory
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Analyzing Data or Information
Collections
Scrutiny and findings
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for BrainSee (DEN220066): decision summary. Granted 2024-01-11.

    This analysis resulted in specificity of 96% (92%, 100%), sensitivity of 73% (65%, 81%), PPV of 97% (93%, 100%), and NPV of 71% (62%, 79%).

Details

AI system

Workflow

The software combined brain volumes from T1-weighted MRI with MMSE and CDR Sum of Boxes scores, age and sex. A score above 50 counted as predicted progression.

Follow-up

Conditions for replication

The patient is 55 to 95 years old with a diagnosis of amnestic mild cognitive impairment. Scores near 50 call for further follow-up, and the score never stands alone.

Entry details

Sector

Healthcare.

Purpose

Darmiyan built BrainSee to help clinicians judge how likely patients aged 55 to 95 with amnestic mild cognitive impairment are to progress to Alzheimer's dementia within five years.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). BrainSee foresaw which memory patients would develop dementia (AIBD-0774). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0774.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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