CDM Insights

by Oxford Brain Diagnostics  · Based in United Kingdom → — Enabling clinicians to diagnose and monitor neurodegenerative conditions, earlier.
Geriatrics Neurology Radiology
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Regulatory Status Disclosed

Overview

CDM Insights, developed by Oxford Brain Diagnostics, is an FDA 510(k)-cleared AI-powered software designed for the early detection and monitoring of neurodegenerative conditions such as Alzheimer’s and Parkinson’s disease. The cloud-native, non-invasive software analyzes standard anatomical and diffusion MRI scan data (from 1.5T and 3T scanners) to provide a deeper understanding of the brain’s microstructure.

Utilizing its proprietary Cortical Disarray Measurement (CDM®) technology, CDM Insights quantifies microstructural changes in the cerebral cortex, cortical thickness, regional volumes, and white matter hyper-/hypointensity volume. It integrates with PACS and delivers comprehensive reports, often within 12 hours, to assist neurologists, radiologists, and other trained healthcare practitioners in their clinical assessments. The tool supports more efficient drug development and personalized patient care by providing objective, quantifiable measures of neurodegeneration.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Quantitative analysis of brain structures
  • Comprehensive reporting
  • Compatible with standard MRI scanners (1.5T and 3T)
  • Measures microstructural change in the cerebral cortex
  • Provides cortical thickness and regional volumes
  • Delivers white matter hyper-/hypointensity volume
  • Cloud-native deployment
  • Non-invasive analysis
  • Integrates with PACS
  • Reports typically available within 12 hours

Use Cases

  • Early detection of neurodegenerative conditions
  • Monitoring progression of neurodegenerative conditions
  • Supporting diagnosis of neurodegenerative conditions
  • Assessing drug efficacy in clinical trials for neurodegenerative diseases
  • Personalized patient care planning
  • Evaluating adults at risk of Alzheimer's disease

What Physicians Need to Know

Brain MRI Analysis
CDM Insights processes standard anatomical and diffusion MRI data from 1.5T and 3T scanners. It provides quantitative analysis of brain structures, microstructural information of the cerebral cortex, cortical thickness, regional volumes, and white matter hyper-/hypointensity volume, all delivered in a single, comprehensive report.
Neurodegenerative Disease Screening
A core function of CDM Insights is the early detection and ongoing monitoring of neurodegenerative conditions, including Alzheimer's disease. The tool identifies subtle microstructural brain changes, offering insights into brain structure alterations before symptom progression and providing a comprehensive assessment of brain health over time.
Triage Prioritization Speed
Clinicians typically receive access to the CDM Insights report within 12 hours of scan upload, facilitating timely patient care.
Physician Tip

CDM Insights is designed for use by neurologists, radiologists, and other trained healthcare practitioners experienced in MRI post-processing. While it empowers clinicians with tools to detect subtle brain changes and provides insights into brain structure alterations prior to symptom progression, it is crucial to remember that the software is not intended for isolated diagnosis or treatment decisions. The physician retains ultimate responsibility for all final diagnostic and treatment decisions.

CDM Insights integrates with Picture Archiving and Communication Systems (PACS) to securely process standard anatomical and diffusion MRI data within a cloud-native environment.

Details

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

CDM Insights received FDA 510(k) clearance (K240680) in January 2025 for clinical brain assessment by trained healthcare practitioners evaluating patients with neurodegenerative disorders such as Alzheimer's disease. It also received Breakthrough Device Designation from the FDA in 2020.
Integrations
EHR Not specified
Specialties Geriatrics, Neurology, Radiology

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Press & Coverage

AuntMinnie
Oxford Brain Diagnostics gets FDA nod for brain MRI software
Oxford Brain Diagnostics' CDM Insights software received 510(k) clearance from the FDA, allowing clinical assessment of brain microstructures via MRI scans for neurodegenerative disorders like Alzheimer's disease. The cloud-native, noninvasive software processes MRI data from 1.5T and 3T scanners and provides new measurements of microstructure and cortical thickness.
2025-01
PR Newswire
Oxford Brain Diagnostics has been granted FDA Clearance for its novel MRI Software u2013 CDM Insights, marking a key advancement in assessing neurodegeneration for patients
Oxford Brain Diagnostics announced FDA 510(k) clearance for CDM Insights, its MRI software powered by Cortical Disarray Measurement (CDMu00ae) technology. This software offers a deeper understanding of brain microstructure from MRI scans to aid in the clinical assessment of neurodegenerative disorders such as Alzheimer's disease.
2025-01
Diagnostic Imaging
FDA Clears Brain MRI-Based Software for Assessing Cortical Disarray Measurement
The FDA granted 510(k) clearance to CDM Insights, an MRI-based software from Oxford Brain Diagnostics, for early detection of neurodegeneration. This cloud-native software provides neuroradiologists with new measurements of brain microstructure and cortical thickness previously unavailable in the U.S.
2025-01
Medical Device Network
Oxford Brain Diagnostics initiates dementia diagnostic commercialisation
Oxford Brain Diagnostics is preparing to launch its cloud-based CDM Insights software, which analyzes MRI scans to detect early signs of dementia. The software received FDA breakthrough device designation in 2020 and 510(k) clearance in January 2025, and will be available to U.S. healthcare facilities.
2025-05
The Imaging Wire
VC Investors Pivot to Quality | Imaging Cost Concerns
Oxford Brain Diagnostics received FDA clearance for CDM Insights, a post-processing solution for MRI brain images, which uses Cortical Disarray Measurement (CDM) technology to derive measures of neurodegeneration for conditions like Alzheimer's disease. The company, launched in 2019, also signed a research agreement with SimonMed last year.
2025-01
accessdata.fda.gov
510(k) Summary for CDM Insights [K240680]
This FDA 510(k) summary details the clearance of CDM Insights, a post-processing image analysis software for viewing, analyzing, and evaluating MR brain images of adults over 45 years of age. The software provides output in standard DICOM format as a DICOM-encapsulated PDF report.
2024-12
Oxford Brain Diagnostics
Oxford Brain Diagnostics Advances Vision for Measuring Brain Health and Neurodegenerative Disease with Five New Studies at AAIC 2026
New findings presented at AAIC 2026 demonstrate the potential of Oxford Brain Diagnostics' MRI-based Cortical Disarray Measurement (CDMu00ae) technology to support patient identification, disease characterization, treatment monitoring, and therapeutic development across Alzheimer's disease. CDMu00ae was granted FDA breakthrough device designation and CDM Insights is FDA 510(k)-cleared.
2026-07
Oxford Brain Diagnostics
New MRI Research Unlocks Earlier Detection of Parkinson's Disease Microstructural Changes
A groundbreaking study, a collaboration involving Oxford Brain Diagnostics and AbbVie, identified a new way to detect early signs of Parkinson's disease using advanced brain imaging. Diffusion MRI can reveal microscopic 'disarray' in the brain's cortex years before traditional symptoms appear.
unknown

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Frequently Asked Questions

CDM Insights aims to streamline administrative tasks, identify trends in patient data for proactive care, and potentially offer decision support by analyzing large datasets. This can help physicians optimize resource allocation and personalize treatment plans.
Yes, any reputable healthcare AI solution like CDM Insights must be designed with robust security measures and strict adherence to HIPAA, GDPR, and other relevant data privacy regulations to protect patient information. Data encryption and access controls are typically paramount.
While powerful, AI tools like CDM Insights are based on algorithms and data, which can have inherent biases or limitations. Physicians must exercise clinical judgment, as the AI's recommendations are supplementary and not a substitute for professional medical expertise, especially in complex or rare cases.
Alternatives might include other AI-driven EHR add-ons, specialized diagnostic AI tools, or advanced analytics platforms. CDM Insights differentiates itself by focusing on specific functionalities and integration capabilities tailored to clinical data management or chronic disease management.
Pricing for healthcare AI solutions often varies based on the size of the practice, features utilized, and data volume. Typically, CDM Insights would offer tiered subscription models, potentially including per-user or per-provider fees, with options for annual or monthly billing.
CDM Insights employs advanced encryption protocols, access controls, and regular security audits to safeguard patient data. It operates under strict data governance policies, ensuring data is anonymized or de-identified where appropriate and only used for its intended purpose.
Effective integration with existing EHR systems is crucial for any healthcare AI tool. CDM Insights is designed to integrate with common EHR platforms through APIs, aiming to minimize disruption to current workflows and ensure smooth data flow.

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