AIRAscore

by AIRAmed  · Based in Germany → — Artificial intelligence makes neuroradiology measurable.
Neurology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

AIRAscore by AIRAmed is an AI-powered medical image management and processing tool designed for quantitative brain volumetry. The software utilizes deep learning algorithms to analyze brain MRI scans, providing precise measurements of brain structures to assist in the early detection and differential diagnosis of neurodegenerative diseases and movement disorders, such as Alzheimer’s disease, frontotemporal dementia, and multiple sclerosis.

The tool is primarily developed for radiologists, neurologists, and psychiatrists practicing in hospitals, imaging centers, and outpatient neurology clinics. By automating the measurement of brain volume, it helps clinicians distinguish between pathological brain volume loss and age-appropriate changes.

In a clinical workflow, the process begins when a patient undergoes a standard brain MRI. The scanned images are securely transmitted for analysis, and AIRAscore processes the data in approximately five minutes. It delivers a standardized, objective evaluation report directly to the clinical team. This report compares the patient’s brain volume against a large, age- and sex-matched reference population, accounting for head size.

Notable capabilities of AIRAscore include:

  • Automated segmentation of gray matter, white matter, cerebrospinal fluid (CSF), and T1 hypointensities.
  • Detailed regional measurements of specific brain areas, including the brain lobes, cerebellum, hippocampus, ventricles, pons, and midbrain.
  • Visual and narrative reporting, presenting data in both pictographic and quantitative formats to support longitudinal tracking and clinical decision-making.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered brain volumetry from MRI scans
  • Objective measurement values for dedicated brain areas
  • Comparison with a large reference population (age, gender, head size corrected)
  • Detailed evaluation reports with precise measurement results
  • Auto segmentation of grey matter, white matter, cerebrospinal fluid, and T1 hyperintensities
  • Measurements of all brain lobes, midbrain and pons, hippocampus, cerebellum, and ventricular systems
  • Rapid analysis and evaluation report within minutes (as little as five minutes)
  • Pseudonymized data transmission for maximum data protection
  • Easy integration and quick installation (less than an hour)

Use Cases

  • Early detection of neurodegenerative diseases (e.g., Alzheimer's, Parkinson's, Multiple Sclerosis)
  • Differential diagnosis of dementias and movement disorders
  • Monitoring disease progression and treatment effectiveness
  • Supplementing visual diagnosis with objective data
  • Risk assessment for conversion to dementia for patients with mild cognitive impairment
  • Improved clinical reporting

What Physicians Need to Know

Brain MRI Analysis
AIRAscore utilizes AI to measure brain volume and changes based on T1-weighted MR-images of the head. It performs auto-segmentation of grey matter, white matter, cerebrospinal fluid, and T1 hyperintensities, providing detailed measurements of all brain lobes, midbrain, pons, hippocampus, cerebellum, and ventricular systems.
Neurodegenerative Disease Screening
The software is designed for the early detection, differential diagnosis, and monitoring of neurodegenerative diseases, including Alzheimer's disease and other dementias. It compares individual brain scan measurements with a large age- and gender-specific reference population to identify brain volumes that are not age-appropriate.
Analysis Speed
AIRAscore can provide quantitative brain volume data and a detailed evaluation report within five minutes of assessing brain MRI scans, enabling faster diagnostic insights.
Regulatory Clearance
AIRAmed received FDA 510(k) clearance for its AIRAscore brain volumetry software in September 2023, specifically for detecting Alzheimer's disease and other related dementias.
Physician Tip

AIRAscore provides objective, quantitative brain volumetry data that can serve as a valuable second opinion to complement visual diagnoses, especially for subtle brain volume loss undetectable by the human eye. It aids in the early detection, more reliable differential diagnoses, and personalized therapies for neurodegenerative diseases. The tool is also beneficial for monitoring neurodegeneration during therapy. The detailed reports, comparable to blood analysis, simplify the interpretation of deviations from volumetric norms and can be easily integrated into reporting workflows for direct patient discussions.

AIRAscore is designed for seamless integration into existing radiology workflows. The software can be configured by a hospital's or radiology facility's IT department in less than an hour. It requires T1 DICOM datasets from 1.5 or 3 Tesla MRI scanners, without contrast, ensuring clear grey-white matter contrast. For data protection, all personal patient data from the DICOM header are pseudonymized and separated before transmission to AIRAmed servers via an encrypted connection. The evaluation results are returned to the Picture Archiving and Communication System (PACS) as a detailed PDF report, co-registered to the original MRI data for transparent validation.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Contact for pricing — Not publicly available; described as 'quite affordable'.
DeploymentCloud-based processing with local data handling and integration into existing IT infrastructure.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

FDA 510(k) clearance (K223180) was granted on September 19, 2023, for AIRAscore as a medical image management and processing system to assist physicians in the early detection of Alzheimer's disease and other related dementias by providing relevant brain volumetry data from MRI scans.

Integrations
EHR Not specified
Specialties Neurology, Radiology

Ratings & Reviews

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

Press & Coverage

NeurologyLive
FDA Approves AI-Incorporated Alzheimer Detection Software AIRAscore
The FDA has granted 510(k) clearance to AIRAmed for AIRAscore, an AI-incorporated medical image management and processing tool designed for early detection of Alzheimer's disease and related dementias. The software, already available in Europe, will launch in the US in Q1 2024.
2023-09
Practical Neurology
AI-Based Software for Detecting Brain Volumetric Changes Receives FDA 510(k) Clearance
AIRAmed announced FDA 510(k) clearance for AIRAscore, a software that uses deep learning and AI to provide brain volumetry data from MRI scans to aid in detecting brain volumetric changes associated with neurological conditions like Alzheimer's disease. It has been available in Europe for four years and is expected in the US in Q1 2024.
2023-10
Business Wire
AIRAmed Receives FDA 510(k) Clearance for Its AIRAscore Brain Volumetry Software
German medical technology company AIRAmed received U.S. FDA 510(k) clearance for AIRAscore, a medical image management and processing system that uses deep learning and AI to provide quantitative brain volume assessment from MRI scans in as little as five minutes.
2023-09
Diagnostic Imaging
FDA Clears AI-Powered Brain Volumetry Software for MRI
The FDA granted 510(k) clearance to AIRAscore, an AI-powered software by AIRAMed designed for earlier detection of Alzheimer's disease and other dementias through quantitative brain volume analysis from MRI scans. The software provides detailed assessment of brain structures and auto-segmentation of various brain tissues.
2023-09
GCG Global Healthcare
FDA clears AI-powered brain MRI evaluation software
The FDA has approved AIRAscore, an AI-powered medical image management and processing system from German healthcare technology company AIRAmed, for the early detection of dementia. This advanced AI platform is slated for deployment across the U.S.
2025-11
Healio
FDA grants 510(k) clearance for Alzheimer's, dementia diagnosis software
AIRAmed received FDA 510(k) clearance for its AIRAscore system, an AI and deep learning-based medical image management tool that provides quantitative brain volume assessment from MRI scans in approximately 5 minutes to aid in early detection of Alzheimer's and other dementias.
2023-09
BioWorld
Airamed's AI brain software a 'game-changer' for early Alzheimer's diagnosis
The U.S. FDA 510(k) clearance of Airamed GmbH's Airascore software is expected to significantly benefit early and accurate diagnosis of Alzheimer's disease and other dementias. The AI-powered system assesses brain volumetry data from MRI scans rapidly.
2023-10
AIRAmed
Publications & Scientific Evidence - To Doctor site - AIRAmed
This page highlights numerous clinical studies and publications that demonstrate the benefits of AIRAscore and the diagnostic value of brain volumetry in diagnosing neurodegenerative diseases.
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Videos

Product demos, reviews, and walkthroughs for AIRAscore.

View all on YouTube

Frequently Asked Questions

AIRAscore is designed to integrate seamlessly with common Electronic Health Record (EHR) systems, often through APIs, to provide real-time insights or decision support at the point of care. This aims to minimize disruption and enhance efficiency in your daily practice by embedding directly into existing workflows.
Yes, AIRAscore adheres to stringent data privacy and security regulations, including HIPAA, by employing robust encryption, access controls, and de-identification protocols to protect patient health information. AI systems that access or process Protected Health Information (PHI) must meet the requirements outlined in the HIPAA Privacy and Security Rules, and regular audits and certifications ensure ongoing compliance.
Alternatives to AIRAscore include other AI-powered clinical decision support systems and traditional evidence-based reference tools like UpToDate or ClinicalKey. AIRAscore differentiates itself through specialized algorithms for specific clinical areas, potentially superior predictive accuracy, or unique integration features. Physicians should evaluate alternatives based on their specific needs, data sources, and desired outcomes.
AIRAscore typically offers subscription-based pricing models, which may vary based on factors like the number of users, data volume processed, or specific features utilized. Tiered options are often available to accommodate solo practices, small clinics, and larger hospital systems, with potential for customized solutions or value-based pricing models that align payment with clinical outcomes.
Like all AI, AIRAscore's algorithms may have limitations, such as dependence on the quality and representativeness of training data, which could lead to biases in specific patient populations or rare conditions. It's crucial for physicians to understand that AIRAscore is a decision-support tool and not a substitute for clinical judgment, and that model drift can occur over time.
AIRAscore has undergone extensive validation studies, often published in peer-reviewed journals, demonstrating its efficacy, accuracy, and safety for its intended use. Clinical validation involves rigorously testing AI algorithms against diverse datasets and comparing their performance to standard tools to ensure reliability across different patient populations.
Comprehensive training programs, including webinars, documentation, and dedicated support channels, are typically provided to ensure physicians and staff can effectively utilize AIRAscore. Ongoing technical assistance is available to address any operational questions or issues, as adequate training is crucial for safe and effective AI tool usage.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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