VUNO Med-DeepBrain

by VUNO  · Based in South Korea → — View the Invisible, Know the Unknown
Geriatrics Neurology Radiology
Website
Claim this tool
Is this the maker? Claim the company →

Contact for pricing
Regulatory Status Disclosed

Overview

VUNO Med-DeepBrain is an AI-based medical device designed for the quantitative analysis of the brain from MRI scans. It aids in the diagnosis of neurodegenerative diseases, including Alzheimer’s disease and vascular dementia, by automatically segmenting the brain into over 100 regions. The software provides volumetric data, evaluates white matter hyperintensity and cortical thickness, and compares individual patient data to healthy populations to generate normative percentile scores. This information is presented in customizable reports, assisting healthcare professionals in early detection and management of conditions that cause brain volume change and atrophy. The software is designed to integrate seamlessly with existing workflows, including PACS, and can analyze MRI images within approximately one minute.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based brain volumetric software
  • Extracts quantitative data from MRI scans
  • Brain parcellation into over 100 regions
  • Provides volumetric data on multiple brain regions
  • Evaluates white matter hyperintensity (WMH) and cortical thickness
  • Compares patient atrophy data to healthy populations
  • Provides normative percentile scores and volume information
  • Customizable reports with statistical analysis, graphs, and diagrams
  • Analyzes brain MRI images within 1 minute
  • Seamless integration with PACS (DICOM standard)

Use Cases

  • Diagnosis of Alzheimer's disease (AD)
  • Diagnosis of other neurodegenerative conditions
  • Early detection of dementia
  • Predicting amyloid positivity in subjective cognitive decline (SCD)
  • Assessing cerebral small vessel disease
  • Monitoring complications from anti-amyloid therapy (ARIA)

What Physicians Need to Know

Brain MRI Analysis
VUNO Med-DeepBrain is an AI-based software that performs quantitative analysis of brain MRI scans. It segments the brain into over 100 distinct regions, providing volumetric data, evaluating white matter hyperintensity (WMH), and cortical thickness.
Neurodegenerative Disease Screening
The tool aids in the diagnosis of neurodegenerative conditions such as Alzheimer's disease and other disorders causing brain volume change and atrophy. It compares individual patient atrophy data to healthy populations, offering normative percentile scores and volume information.
Analysis Speed
VUNO Med-DeepBrain can analyze a brain MRI image and provide parcellation results within 1 minute, aiming to reduce time to diagnosis.
Early Detection Potential
The software has demonstrated effectiveness in predicting amyloid positivity in individuals with subjective cognitive decline (SCD), suggesting its utility in the early detection of Alzheimer's disease.
Report Generation
It generates customizable reports that include statistical analysis results, visualized graphs, and diagrams, enhancing communication and patient understanding.
Regulatory Clearances
VUNO Med-DeepBrain has received FDA 510(k) clearance in the United States, CE Mark in Europe, and approval from MFDS (Korea).
Physician Tip

Leverage VUNO Med-DeepBrain's quantitative brain data, including volumetric measurements, cortical thickness, and white matter hyperintensity, for objective assessment of neurodegenerative changes. Utilize the normative percentile scores to compare patient data against healthy populations, aiding in the early identification and monitoring of conditions like Alzheimer's disease. The rapid 1-minute analysis speed can significantly streamline workflow, allowing for quicker diagnostic insights. Employ the customizable reports for clear communication with patients and for tracking disease progression over time.

VUNO Med-DeepBrain is designed for seamless integration with existing Picture Archiving and Communication Systems (PACS) through the DICOM standard format. It accepts 3D T1-weighted and 2D T2 FLAIR brain MR images as input. The system provides output in the form of comprehensive reports, including statistical analysis, visualized graphs, and diagrams, which can be easily incorporated into clinical documentation.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentCloud-based service, PACS integration
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

VUNO Med-DeepBrain received FDA 510(k) clearance (K231398) on October 4, 2023. The software automates the identification, labeling, and quantification of segmentable brain structures from MRI images to assist in diagnosing neurodegenerative conditions.
Integrations
EHR Not specified
Specialties Geriatrics, Neurology, Radiology

What the Web Says

VUNO Med-DeepBrain is an AI-powered medical device designed to assist in the diagnosis of neurodegenerative diseases, including Alzheimer's disease and vascular dementia, by quantitatively analyzing brain MRI images. It automates the process of segmenting over 100 brain regions, quantifying brain volume, atrophy, cortical thickness, and white matter hyperintensity, and comparing these metrics to a normal population to provide normative percentile scores. The software aims to improve the efficiency and accuracy of diagnosis, potentially enabling earlier detection of conditions like dementia even before mild cognitive impairment.

Overall: Positive

Strengths

  • Automates and speeds up the analysis of brain MRI images, providing results within one minute.
  • Aids in the early detection and diagnosis of neurodegenerative diseases like Alzheimer's and vascular dementia.
  • Provides quantitative data on over 100 brain regions, including volume, atrophy, cortical thickness, and white matter hyperintensity.
  • Compares patient data to a normal population, offering normative percentile scores for better clinical interpretation.
  • Offers customizable reports with statistical analysis, graphs, and diagrams to enhance patient understanding and satisfaction.
  • Received FDA 510(k) clearance in the U.S. and national health insurance coverage in Korea.

Limitations

  • No specific cons were identified in the provided search results.
  • No specific cons were identified in the provided search results.
  • No specific cons were identified in the provided search results.
  • No specific cons were identified in the provided search results.
  • No specific cons were identified in the provided search results.
  • No specific cons were identified in the provided search results.

Based on reviews from: VUNO, BioWorld, KBR, Practical Neurology, Medical Device Network, AuntMinnie, ESR Connect, KED Global, MedTech Innovator, App Commons, FDA, PR Newswire, PMC

Last updated: 2026-07-20

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate VUNO Med-DeepBrain

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

KBR
VUNO to launch AI-backed dementia detecting device at AAIC 2024 in US
VUNO announced its participation in the Alzheimer's Association International Conference (AAIC) 2024 to officially launch its FDA-certified AI-based brain imaging analysis medical device, VUNO Med-DeepBrain, in the U.S. market. The device analyzes brain MRI images to quantify atrophy in over 100 brain regions, aiding in the diagnosis of dementia and pre-screening for progression from mild cognitive impairment.
2024-07
PR Newswire
VUNO Secures FDA 510(k) Clearance for VUNO Medu00ae-DeepBrainu00ae
VUNO Inc. received 510(k) clearance from the U.S. FDA for its AI-powered brain quantification device, VUNO Med-DeepBrain. This device automates the process of identifying, labeling, and quantifying segmentable brain structures from MRI images, providing volumetric data on over 100 brain regions.
2023-10
BioWorld
FDA clears Vuno's AI-based MRI reading software for early Alzheimer's detection | BioWorld
Vuno Inc. obtained U.S. FDA 510(k) clearance for Vuno Med-Deepbrain, an AI-powered brain quantification device, intended for diagnosing potential dementia even before mild cognitive impairment. The software analyzes over 100 brain regions from MRI images to provide volumetric data, cortical thickness, and white matter hyperintensity in under a minute.
2023-10
Diagnostic Imaging
FDA Clears Emerging AI Software for Brain MRI | Diagnostic Imaging
The VUNO Med-DeepBrain AI software has received 510(k) clearance from the FDA, offering a time-saving solution for automated identification and quantification of brain structures on MRI. The software provides volumetric information on over 100 brain regions, cortical thickness, and white matter hyperintensity, potentially aiding in earlier dementia diagnosis.
2023-10
Practical Neurology
AI-Based Brain Volumetric Software, VUNO Med-DeepBrain, Receives FDA 510(k) Clearance - Practical Neurology
VUNO Med-DeepBrain, an AI-based software that extracts quantitative brain data from MRI scans, has received FDA 510(k) clearance. The software uses brain parcellation to provide volumetric data on multiple brain regions and evaluates white matter hyperintensity and cortical thickness, with potential applications in diagnosing Alzheimer's and other neurodegenerative conditions.
2023-10
KED Global
Vuno's brain imaging AI medical device secures FDA certification - KED Global
Vuno's AI-powered brain quantification device, Vuno Med-DeepBrain, has received 510(k) certification from the US FDA. This technology analyzes brain MRI scans to segment over 100 distinct areas and quantify atrophy, assisting in the diagnosis of dementia and identifying patients at risk of progressing from mild cognitive impairment.
2023-10
PMC (PubMed Central)
Deep learning-based diagnosis of Alzheimer's disease using brain magnetic resonance images: an empirical study - PMC
This empirical study investigated the diagnostic performance of VUNO Med-DeepBrain AD (DBAD) using 2D brain MRI for Alzheimer's disease diagnosis, comparing its accuracy, sensitivity, and specificity with medical specialists. The study concluded that DBAD could serve as a decision support service, potentially enhancing accessibility to AD diagnosis and treatment.
2022-10
PLOS One
Diagnostic performance of deep learning-based automatic white matter hyperintensity segmentation for classification of the Fazekas scale and differentiation of subcortical vascular dementia | PLOS One
This retrospective study evaluated the diagnostic performance of a deep learning-based automatic white matter hyperintensity (WMH) volume segmentation system, VUNO Med-DeepBrain, for classifying Fazekas scale grades and differentiating subcortical vascular dementia. The system, utilizing convolutional neural networks, segments WMH from pre-processed axial FLAIR images.
2022-09

Videos

Product demos, reviews, and walkthroughs for VUNO Med-DeepBrain.

View all on YouTube

Frequently Asked Questions

VUNO Med-DeepBrain automates the quantification of over 100 brain regions from MRI images, providing volumetric data, cortical thickness, and white matter hyperintensity measurements. This data is then compared to a normative population and presented in a customizable report, aiding physicians in the diagnosis and management of conditions like dementia and Alzheimer's disease.
VUNO Med-DeepBrain has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and holds CE Mark certification, indicating compliance with European safety and health protection requirements. It is considered a 'Moderate' level of concern by the FDA, with cybersecurity risks addressed and software validation performed.
While a powerful aid, VUNO Med-DeepBrain is a decision support tool, and its results must always be reviewed and interpreted by a trained physician. Clinical studies have noted limitations such as the number of medical experts involved in validation and potential trade-offs between incorporating more brain regions for enhanced accuracy and maintaining processing speed.
VUNO Med-DeepBrain offers an automated, rapid analysis of brain MRI images, providing quantitative data that can be a promising alternative to more costly or radiation-intensive methods like amyloid-beta PET for screening. While the AI market is competitive, VUNO Med-DeepBrain has demonstrated high consistency in brain volume measurements compared to other solutions.
Specific pricing for VUNO Med-DeepBrain in markets like the US is not publicly detailed in the provided information. However, in South Korea, it has received national health insurance coverage, allowing medical institutions to claim higher reimbursement fees for 3D brain MRI imaging and reading when utilizing the device.
VUNO Med-DeepBrain is designed for seamless integration with current clinical workflows and Picture Archiving and Communication Systems (PACS) by adhering to the DICOM standard format. It can analyze 3D T1-weighted and 2D T2 FLAIR brain MRI images, providing rapid analysis results typically within one minute.

Related Tools

DETECT-ME/CFS project
ME/CFS Research Foundation (Sponsor: Federal Ministry of Health (BMG))
Clinical Decision Support & Reference
The DETECT-ME/CFS project is developing an AI-supported clinical decision support system to improve the rapid and reliable diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
Neurotrack
Neurotrack
Clinical Decision Support & Reference
Neurotrack is a cognitive care enablement platform that provides clinically validated, FDA class II device assessments and care planning support to identify and manage cognitive decline and dementia earlier and with greater accuracy.
LesionQuant
CorTechs Labs
Neurology AI
LesionQuant, an FDA-approved AI product by CorTechs Labs, is particularly useful for patients with multiple sclerosis. It provides brain structure data and quantifies the number, size, and location of lesions, comparing them to prior studies.
ExcelsiusGPS
Globus Medical
Neurology AI
ExcelsiusGPS™ is the first and only robotic navigation platform on the market that offers a comprehensive approach to spine and cranial procedures, from start to finish. The system enables repeatable and accurate trajectory alignment and navigation for placing screws, interbody implants, and cranial instruments.
Paid
Onera SleepMap
Onera B.V.
Neurology AI
Onera SleepMap is an AI-powered sleep analysis software that processes polysomnography data, part of Onera Health's innovative patch-based system for at-home and in-lab sleep studies. The system aims to make clinical-grade sleep diagnostics more accessible and user-friendly, providing comprehensive data comparable to traditional in-lab PSG.
Per-test pricing
JLK-NCCT
JLK-NCCT
Clinical Decision Support & Reference
JLK-NCCT is an AI software designed to assist in the analysis of non-contrast CT brain scans for the detection of acute ischemic stroke.

See all Neurology AI tools →

More from VUNO

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
Vuno
Radiology & Imaging AI
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is an FDA-cleared AI-based software that analyzes adult chest X-rays to rapidly detect pleural effusion and pneumothorax, prioritizing urgent cases in clinical workflows.
Contact for pricing

View company profile →

Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
AI Tool Finder
AI-powered search. Results may not be comprehensive.