BrainSee

by Darmiyan  · Based in United States → — Precision Brain Health Screening & Monitoring for All using our novel medical AI + brain imaging software
Geriatrics Neurology Radiology

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

Neurodegenerative Disease Screening
BrainSee is an FDA-approved AI-powered software platform that predicts the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia within five years. It utilizes advanced AI algorithms to analyze routine clinical brain MRIs and cognitive test results, providing a numerical score (0-100) to indicate a patient's risk level. The technology aims to enable earlier personalized treatment for high-risk patients and reduce anxiety and unnecessary invasive tests for those at lower risk.
Brain MRI/CT Analysis
BrainSee analyzes standard clinical brain MRI data in conjunction with cognitive assessments to generate a prognostic score. The software uses whole-brain image analysis and medical AI technology. Darmiyan's patented core technology quantifies cellular-level changes within every voxel of a brain MRI scan.
Physician Tip

BrainSee provides an objective, non-invasive prognostic tool for patients with amnestic MCI, helping to guide early intervention strategies and manage patient expectations. It can be used to identify suitable candidates for clinical trials and monitor patient response to interventions. The platform is accessible to any licensed physician, including general practitioners, geriatricians, psychiatrists, and preventive medicine specialists. The test can be repeated annually or more frequently to monitor risk changes based on treatments and lifestyle modifications.

BrainSee is accessible to physicians through a secure, HIPAA-compliant web portal. The platform supports remote doctor visits, comprehensive cognitive assessments, MRI prescriptions, and follow-ups. Darmiyan is also exploring collaborations to integrate BrainSee's AI platform into early Alzheimer's disease trial design for pharmaceutical companies.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Unknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Geriatrics, Neurology, Radiology

What the Web Says

BrainSee, developed by Darmiyan, is an AI-powered clinical tool that analyzes standard brain MRI and cognitive assessments to predict the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia within five years. It received FDA De Novo approval in January 2024, marking it as a first-of-its-kind non-invasive prognostic tool for Alzheimer's. Physicians and experts have expressed optimism about its potential to redefine brain health screening and enable earlier, more personalized interventions.

Overall: Positive

Strengths

  • Predicts progression from aMCI to Alzheimer's dementia within 5 years with reported 91% accuracy.
  • Non-invasive, utilizing standard clinical brain MRI and cognitive assessments.
  • Provides objective scores to help physicians determine patient prognosis.
  • Aids in early screening and risk stratification, potentially delaying dementia onset through timely treatments.
  • Reduces the need for costly and invasive tests for low-risk patients.
  • Seamless integration into clinical workflow with same-day test results.

Limitations

  • The FDA approval is for adjunctive use, meaning it's not a stand-alone diagnostic or prognostic tool and should not be used to diagnose aMCI.
  • Some experts suggest that peer-reviewed studies are needed to fully understand the sensitivity and specificity of the approach.
  • The sensitivity in one pivotal study fell below the pre-specified goal.
  • The algorithm's reliance on hippocampal atrophy as a key predictive feature has been noted, and its contribution within the 'black box' of the AI needs further understanding.
  • While BrainSee is available to physicians, there is no information about direct patient access or cost.
  • No reviews from Reddit, G2, or Capterra specifically for Darmiyan's BrainSee were found.

Based on reviews from: Darmiyan, PR Newswire, MCRA, med-tech.world, Engadget, Practical Neurology, MedTech Innovator, Alzheimer's News Today, Medical Device Network, Healthcare Discovery AI, Reportable News, AuntMinnie.com, Alzforum, BrainSee.ai, notebookcheck.net, notebookcheck.nl, Capterra

Last updated: 2026-10-29

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Press & Coverage

Practical Neurology
BrainSee Software Receives FDA Approval for Whole Brain Image Analysis to Assist in Predicting Progression to Alzheimer Disease
BrainSee, a software developed by Darmiyan, received De Novo approval from the FDA in January 2024. It utilizes whole brain image analysis and AI to predict the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's disease within five years. The FDA had previously granted BrainSee breakthrough designation in 2021.
2024-01
PR Newswire
Darmiyan Receives FDA Approval for BrainSee, the First Prognostic Test for Predicting Likelihood of Progression to Alzheimer's Dementia
Darmiyan announced on January 12, 2024, that its BrainSee clinical test received FDA De Novo approval, marking a significant advancement in brain health and Alzheimer's disease diagnosis. BrainSee is a non-invasive, AI-powered software that combines standard clinical brain MRI and cognitive assessments to predict the likelihood of progression from aMCI to Alzheimer's dementia within 5 years.
2024-01
MCRA
MCRA Supports Darmiyan with FDA Approval for BrainSee Device
MCRA announced its role in supporting Darmiyan to secure FDA De Novo approval for BrainSee in January 2024. MCRA had previously helped Darmiyan achieve Breakthrough Device Designation for BrainSee in 2021. BrainSee's AI algorithm uses brain MRI analysis and cognitive test results to predict the likelihood of progression from aMCI to Alzheimer's dementia within 5 years.
2024-05
MedPath
FDA Approves 7-Year Post-Market Study for BrainSee Alzheimer's Progression Prediction Tool
In May 2025, the FDA approved Darmiyan's 7-year post-market surveillance study for BrainSee, an AI-powered tool that predicts Alzheimer's disease progression in patients with mild cognitive impairment. The study aims to validate BrainSee's effectiveness across diverse patient populations and assist pharmaceutical companies in identifying candidates for clinical trials.
2025-05
BioSpace
Darmiyan, Inc. Announces Launch of Groundbreaking BrainSee Platform for Alzheimer's Testing
Darmiyan announced the launch of its BrainSee Platform on September 16, 2024, which integrates the FDA-approved BrainSee Test for Alzheimer's disease. The platform is designed to help individuals with memory concerns assess and monitor their risk of progression to Alzheimer's dementia within five years.
2024-09
Med-Tech.world
BrainSee: Predicting Alzheimer's Progression Before It Happens
Darmiyan's BrainSee, an FDA-authorized AI-powered clinical tool, helps physicians predict the likelihood of Alzheimer's progression in patients over 55 with amnestic mild cognitive impairment (aMCI) within five years. The FDA granted marketing authorization in January 2024 through the De Novo pathway, and a 7-year post-market surveillance study has been approved to validate its real-world utility.
2025-06
AuntMinnie.com
Darmiyan’s BrainSee nabs breakthrough status from FDA
The FDA granted breakthrough status to Darmiyan's AI-based software, BrainSee, in June 2021. BrainSee is designed to detect Alzheimer's disease at the early stage of mild cognitive impairment using non-invasive MRI scans.
2021-06
Reportable News
ASNR Journal: BrainSee Enterprise Software Is Reliable, Accurate for Alzheimer's Disease Detection
On May 24, 2021, the American Society of Neuroradiology published a summary of study results for BrainSee, highlighting its 91% accuracy rate in detecting Alzheimer's disease at early stages. The publication, titled "Introducing BrainSee: A Novel, MRI-based Virtual Microscope Technology for Non-invasive Prognosis of Amnestic MCI in Clinics and Clinical trials," confirmed the technology's high test-retest reliability.
2021-05

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Frequently Asked Questions

BrainSee is an AI-powered software that analyzes brain MRI data, patient demographic information, and cognitive assessment scores (MMSE & CDRSB) to predict the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's disease (AD) dementia within five years. It provides a similarity score between 0 and 100, indicating the degree of similarity between the patient and reference populations of aMCI patients who either progressed or did not progress to AD dementia.
BrainSee received De Novo approval from the FDA in January 2024 and was previously granted breakthrough designation in 2021. It is a prescription-only device intended for adjunctive use, meaning it should be used in conjunction with patient history, clinical observations, and other clinical evidence, not as a stand-alone diagnostic or prognostic tool.
BrainSee is not indicated as a stand-alone diagnostic or prognostic tool and should not be used to diagnose aMCI. The clinical validation study had limitations, including under-representation of certain sociodemographic groups, which will be further addressed in a planned postmarket study. Patient management decisions should not be made solely based on BrainSee's analysis.
BrainSee is a non-invasive software that utilizes standard MRI and cognitive assessments, offering an alternative to more invasive methods like PET scans or cerebrospinal fluid biopsies. While other AI tools are being developed for dementia diagnosis, BrainSee focuses specifically on predicting progression from aMCI to AD dementia within five years.
Physicians can access BrainSee through a secure web portal to create patient records, upload brain MRI scan files, enter MMSE and CDRSB scores, and request analysis. BrainSee uses standard 3D T1-weighted brain MRI sequences (MPRAGE or IR-FSPGR, 1 mm isotropic) acquired at 1.5T or 3T, without the need for contrast agents or special hardware.

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