BrainSee

by Darmiyan  · Based in United States → — Revolutionizing Alzheimer's Diagnosis with AI-powered BrainSee
Geriatrics Neurology Radiology
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Brainsee costs $1,500, with an offered price of $300 pending medicare coverage.
Regulatory Status Disclosed

Overview

Darmiyan is a pioneering brain health technology company focused on developing innovative and rapidly scalable products for brain health screening and monitoring. Its flagship product, BrainSee, is an AI-powered virtual microscope of the human brain designed for the early detection, visualization, and quantification of neurodegenerative disorders, specifically Alzheimer’s disease. BrainSee leverages cutting-edge image processing and medical Artificial Intelligence to predict the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer’s dementia within a five-year timeframe. It seamlessly integrates standard clinical brain MRI and cognitive assessments to generate an objective risk score, aiming to redefine brain health screening and monitoring standards.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered whole-brain image analysis
  • Predicts progression from aMCI to Alzheimer's dementia within 5 years
  • Utilizes standard clinical brain MRI and cognitive assessments (MMSE, CDR-SB)
  • Generates an objective risk score (0-100)
  • Non-invasive
  • High prognostic accuracy (91% in studies)
  • Same-day test results
  • Secure, HIPAA-compliant web portal
  • Integrates effortlessly into existing clinical workflows
  • Virtual Microscope technology (DarmiScope)

Use Cases

  • Early detection and prognosis of Alzheimer's disease
  • Risk stratification for patients with amnestic mild cognitive impairment (aMCI)
  • Guiding early intervention and personalized treatment strategies
  • Reducing the need for costly and invasive tests
  • Identifying optimal candidates for Alzheimer's clinical trials
  • Monitoring risk and treatment efficacy over time

What Physicians Need to Know

Brain MRI Analysis
BrainSee utilizes advanced AI algorithms to analyze standard clinical brain MRI scans, quantifying cellular-level changes within every voxel to assess brain tissue architecture.
Neurodegenerative Disease Screening
BrainSee is an FDA-approved prognostic tool that predicts the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia within five years. It achieves high prognostic performance accuracy, with studies showing up to 91% accuracy. It combines MRI data with cognitive assessment scores (e.g., MMSE, CDR-SB) to generate an objective risk score from 0 to 100.
Triage Prioritization Speed
The platform provides same-day test results, enabling timely risk stratification and personalized treatment planning for patients with aMCI. This helps guide early interventions for high-risk patients and reduces the need for costly, invasive tests for those at lower risk.
Mobile Access
BrainSee is available to physicians through a secure and HIPAA-compliant web portal. A mobile application is also available, allowing patients to take charge of their health anytime, anywhere.
Physician Tip

BrainSee serves as a valuable adjunctive prognostic tool for patients aged 55-95 diagnosed with amnestic mild cognitive impairment (aMCI), aiding in the assessment of their likelihood to progress to Alzheimer's dementia within five years. It is non-invasive, leverages routine brain MRI and cognitive scores, and provides objective, quantitative risk scores (0-100) on the same day. This allows for early risk stratification, guiding personalized treatment strategies, lifestyle modifications, and clinical trial eligibility, while potentially reducing unnecessary invasive testing for low-risk individuals. Patient management decisions should not be made solely on BrainSee results, but rather in conjunction with a standard neurological assessment. The test can be repeated annually or more frequently to monitor risk changes.

BrainSee is a highly scalable and fully automated software platform designed for seamless integration into existing clinical workflows. It processes standard clinical brain MRI data and cognitive assessment scores, making it compatible with widely available diagnostic infrastructure. The platform is accessible via a secure web portal for physicians, and a patient-facing mobile application is also available.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Brainsee costs $1,500, with an offered price of $300 pending medicare coverage. — $1,500; $300 (pending Medicare coverage); Medicare covers MRI scans.
DeploymentCloud-based software platform, accessible via web portal.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

BrainSee received De Novo approval from the FDA in January 2024 as a first-in-class clinical test to predict the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia within five years. It also received FDA breakthrough designation in 2021.
Integrations
EHR Not specified
Specialties Geriatrics, Neurology, Radiology

What the Web Says

BrainSee, developed by Darmiyan, is an FDA-approved AI-powered software that analyzes standard brain MRI scans and cognitive assessment scores to predict the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia within five years. Physicians and healthcare professionals have expressed optimism about its potential to provide early, non-invasive, and objective prognostic information, aiding in timely interventions and personalized treatment plans. The technology aims to shift the paradigm from reactive to proactive management of Alzheimer's disease.

Overall: Positive

Strengths

  • High prognostic accuracy (91%) in predicting progression to Alzheimer's dementia.
  • Non-invasive, utilizing standard clinical MRI and cognitive assessments.
  • Provides objective, quantifiable risk scores (0-100) to aid physician prognosis.
  • Offers same-day test results, facilitating timely clinical decisions.
  • Aids in personalized treatment plans and can help reduce reliance on expensive and invasive procedures.
  • FDA-approved and received Breakthrough Device designation.

Limitations

  • Some experts suggest that the prognostic output might heavily rely on hippocampal atrophy, a known predictor, and call for more peer-reviewed studies to fully understand sensitivity and specificity.
  • The software is a prescription-only device and not a standalone diagnostic or prognostic tool; physicians are cautioned against using it if input reliability is a concern.
  • Interpretation of scores close to 50 may be challenging as they indicate similarity to both converter and non-converter aMCI patient populations.
  • Limited information available from independent tech reviewers, Reddit, G2, or Capterra specifically for BrainSee, with general discussions on AI in medical imaging or review platforms themselves.

Based on reviews from: MedTech Innovator, Darmiyan, Research (Geras Centre for Aging Research), BrainSee (Darmiyan product website), Xtalks, Alzforum, Right at Home, MCRA, MedTech World, Notebookcheck, accessdata.fda.gov, Contemporary OB/GYN (via emedicine.medscape.com), Reddit, G2, Capterra

Last updated: 2026-07-18

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Press & Coverage

PR Newswire
Darmiyan Receives FDA Approval for Post-Market Surveillance Study of BrainSee, the First-in-Class Clinical Test for Predicting Risk of Progression to Clinical Alzheimer's Disease
Darmiyan announced FDA approval for a 7-year post-market surveillance study for BrainSee, an AI-powered tool that predicts the risk of progression to clinical Alzheimer's disease in patients with amnestic mild cognitive impairment (aMCI) within five years. BrainSee received FDA marketing authorization in January 2024 via the De Novo pathway.
2025-05
MedTech World
Darmiyan's BrainSee Gets FDA Nod for Alzheimer's Prognostic Study
Darmiyan's BrainSee, an FDA-authorized AI-powered clinical tool, received FDA approval for a 7-year post-market surveillance study to further validate its safety and effectiveness in a diverse patient population. BrainSee helps physicians predict the likelihood of Alzheimer's progression in patients over 55 with aMCI.
2025-05
PR Newswire
Darmiyan, Inc. Announces Launch of Groundbreaking BrainSee Platform for Alzheimer's Testing
Darmiyan announced the launch of the BrainSee Platform, which integrates the FDA-approved BrainSee Test for Alzheimer's disease, designed to help individuals with memory concerns assess their risk of progression to Alzheimer's dementia. The platform, available nationwide starting September 16, 2024, offers remote doctor visits, cognitive assessments, and MRI prescriptions.
2024-09
MCRA, LLC
MCRA Supports Darmiyan with FDA Approval for BrainSee Device
MCRA announced its role in supporting Darmiyan to achieve FDA De Novo approval for BrainSee in January 2024, following a Breakthrough Device Designation in 2021. BrainSee's AI algorithm combines brain MRI analysis and cognitive test results to predict the likelihood of progression from aMCI to Alzheimer's dementia within 5 years.
2024-05
Practical Neurology
BrainSee Software Receives FDA Approval for Whole Brain Image Analysis to Assist in Predicting Progression to Alzheimer Disease
The FDA granted De Novo approval to BrainSee in January 2024, a first-in-class clinical test that uses whole brain image analysis and medical AI to predict the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's disease within 5 years. BrainSee previously received breakthrough designation in 2021.
2024-01
Pharmacy Times
FDA Approves BrainSee, First-in-Class Test to Predict Progression of Alzheimer Disease
The FDA approved BrainSee, a first-in-class clinical test that uses imaging processing and medical AI to predict the progression from aMCI to Alzheimer's dementia. This non-invasive screening process aims to redefine brain health screening and monitoring standards.
2024-01
Fierce Biotech
FDA clears AI that predicts Alzheimer's progression from an MRI scan
The FDA granted De Novo clearance to BrainSee, an AI program that analyzes standard brain MRI scans and cognitive test scores to predict a patient's chances of progressing from mild cognitive impairment to Alzheimer's disease within five years. BrainSee received breakthrough designation in 2021.
2024-01
Diagnostic Imaging
AI Combination of Brain MRI and Cognitive Assessments May Predict aMCI Progression to Alzheimer's Dementia
The FDA granted De Novo approval for BrainSee, an AI-powered software platform that combines brain MRI and cognitive assessments to predict up to a five-year progression of aMCI to Alzheimer's dementia. This technology aims to facilitate personalized treatment for high-risk patients and reduce anxiety and costs for lower-risk individuals.
2024-01

Videos

Product demos, reviews, and walkthroughs for BrainSee.

View all on YouTube

Frequently Asked Questions

BrainSee is an FDA-approved AI-driven software that analyzes standard brain MRI scans, along with MMSE and CDR-SB scores, to predict the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia within five years. Physicians, including neurologists, geriatricians, psychiatrists, and primary care providers, can upload patient data to a secure web portal for same-day results, which serves as an adjunct to their clinical assessment.
BrainSee received FDA De Novo approval in January 2024, following a Breakthrough Device Designation in 2021, classifying it as a prescription-only Class II medical device. It is intended for adjunctive use, meaning it aids clinical assessment and is not a standalone diagnostic tool, and is accessible via a secure, HIPAA-compliant web portal.
BrainSee has demonstrated a prognostic performance accuracy of 91% in one study and 84.3% balanced accuracy in another, outperforming traditional hippocampal volume analysis. However, it is crucial to remember that BrainSee is an adjunctive tool, not a standalone diagnostic, and some validation studies had limitations regarding under-represented sociodemographic groups.
BrainSee is listed at a cost of $1,500, though Darmiyan offers it for $300 while awaiting Medicare coverage. Medicare currently covers the cost of the MRI scans themselves, which typically average around $1,000 for out-of-pocket patients.
Alternatives include emerging blood-based biomarkers, such as plasma p-tau217 immunoassays, which show high accuracy (90-95%) and are vying for regulatory approval. Traditional methods like amyloid-PET scans and CSF biomarkers are also used, though they can be more invasive, costly, and have accessibility limitations compared to BrainSee's non-invasive approach.
BrainSee operates through a secure, HIPAA-compliant web portal where physicians upload patient MRI scan files and cognitive assessment scores. This ensures that sensitive patient data is handled in accordance with privacy regulations throughout the analysis process.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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