MR DWI/FLAIR Measurement

by Olea Medical  · Based in France →Intelligent automated solutions that instantly provide you with key information
Neurology Radiology

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Regulatory Status Disclosed

Overview

Olea Medical’s MR DWI/FLAIR Measurement V1.0 is an image processing application and Picture Archiving Communications System (PACS) software module. It is designed to assist trained professionals, including physicians and medical technicians, in the imaging assessment workflow for MR Diffusion-weighted imaging (DWI) and MR FLAIR images. The tool processes isotropic images, computes parametric maps such as Apparent Diffusion Coefficient (ADC) maps, and extracts and communicates key metrics like hypointense areas on ADC and FLAIR series, as well as ratios with contralateral information on FLAIR images. This solution aims to streamline workflows and enhance diagnostic confidence, particularly in time-sensitive neurovascular emergency cases like stroke.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • MR DWI and FLAIR image processing
  • ADC map computation
  • Extraction of hypointense area on ADC maps
  • FLAIR series analysis and contralateral ratios
  • Automated stroke map generation
  • Workflow streamlining
  • Multi-vendor compatibility
  • Quantitative and qualitative imaging analysis
  • Support for diagnostic confidence
  • Real-time processing and automated reporting

Use Cases

  • Stroke diagnosis and assessment
  • Neurovascular emergency management
  • General MR DWI/FLAIR study analysis
  • Patient triage in radiology
  • Brain tumor surgical planning (as part of broader Olea solutions)
  • Breast lesion characterization (as part of broader Olea solutions)

What Physicians Need to Know

Stroke Detection Speed
Automatically generates stroke maps in seconds, providing a rapid and reliable tool for stroke detection. Post-processing tools automate lesion segmentation, volume calculation, and perfusion mapping, significantly accelerating decision-making in acute stroke cases.
Brain MRI/CT Analysis
Offers multi-vendor post-processing solutions for MRI and CT images, enabling analysis of 2D, 3D, and 4D data with standardized workflows. The MR DWI/FLAIR Measurement V1.0 processes DWI and FLAIR sequences to generate relative and normalized FLAIR images and compute ADC maps. It includes diffusion-perfusion analysis with mismatch assessment and automated restrictive diffusion and hypoperfused volume extraction.
Large Vessel Occlusion Detection
The Neurovascular Solution and autoNeurovascular solution incorporate AI-driven detection of Large Vessel Occlusions (LVOs) in the anterior circulation (Distal ICA, M1 & Proximal M2) on CT imaging. The AUTOStroke Solution LVO application accurately identifies ICA and M1 MCA occlusions.
Triage Prioritization Speed
AI-driven solutions facilitate rapid detection of urgent pathologies like stroke, reducing wait times by accelerating image analysis. The Automation Platform V1.5 and autoNeurovascular solution prioritize and triage clinical cases efficiently, optimizing hospital patient flow.
ASPECTS Score Automation
Provides AI-based ASPECTS hypodensity probability heat maps for CT imaging. It is a core component of the e-STROKE SUITE, which includes e-ASPECTS.
Mobile Notification System
Features a dedicated mobile application for the Neurovascular Solution, delivering real-time alerts, notifications, and patient image overviews. This system allows for notification and visualization of key findings on the go.
Physician Tip

Leverage the MR DWI/FLAIR Measurement tool for rapid, standardized, and objective assessment of acute stroke, utilizing its automated stroke map generation and diffusion-perfusion analysis. The AI-driven LVO detection and ASPECTS score automation can significantly enhance diagnostic confidence and streamline decision-making in time-critical situations. Utilize the mobile notification system for immediate access to critical findings and improved communication within the stroke care team, facilitating faster intervention and potentially better patient outcomes.

The solution seamlessly integrates with Picture Archiving and Communication Systems (PACS) for automated, structured reporting and export of results. A key integration is with Pulsara, enabling real-time communication, notifications of new image results, and direct links to the Olea Medical Neurovascular App for advanced imaging features on mobile devices, thereby enhancing coordinated stroke care across the patient journey. The platform is designed as a multi-vendor and multi-modality solution, ensuring compatibility with various MR and CT scanners.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Contact vendor N/A
DeploymentOn-premise (PACS software module), Cloud Hosted, Web-Based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

MR DWI/FLAIR Measurement V1.0 (K230552) received FDA clearance on April 26, 2023. It is an image processing application indicated for use in the analysis of MR Diffusion-weighted imaging (DWI) and MR FLAIR images by trained professionals in the imaging assessment workflow.

Integrations
EHR Not specified
Specialties Neurology, Radiology

What the Web Says

Olea Medical's MR DWI/FLAIR Measurement V1.0 is an image processing application designed to assist trained professionals in analyzing MR Diffusion-weighted imaging (DWI) and Fluid-Attenuated Inversion Recovery (FLAIR) studies, particularly for stroke detection and assessment. The software automatically generates relative and normalized FLAIR images and extracts metrics like hypointense areas on ADC and FLAIR series, as well as ratios with contralateral information on FLAIR images. It is intended for use in healthcare facilities and is considered substantially equivalent to its predicate device, Olea Sphere V3.0.

Overall: Positive

Strengths

  • Automated generation of stroke maps in seconds, providing a reliable and quick tool for radiologists.
  • Assists in the analysis of stroke cases, where quick intervention is crucial.
  • Can help detect and prioritize life-threatening conditions.
  • Improved diagnostic information for better patient care.
  • Performs equivalent to or even better than domain experts in binary classification of time since stroke onset (within +/- 4.5 hours).
  • Offers advanced postprocessing of diffusion imaging, compatible with clinical practice expectations in terms of time-effectiveness and clinical impact, particularly in breast lesion assessment.

Limitations

  • Patient management decisions should not be based solely on the results of the software.
  • Current AI methods for DWI/FLAIR mismatch assessment may not accurately determine the exact time since stroke onset based only on DWI and FLAIR sequences.
  • The relation between time since stroke onset and increasing visibility of FLAIR hyperintensity lesions is not recommended for determining time since stroke onset within the first 4.5 hours.
  • Inter-rater agreement for visual grading of FLAIR hyperintensity can be moderate.
  • Conventional MRI sequences (including DWI/ADC and FLAIR) might not be sensitive enough for minute microstructural alterations in white matter diseases.

Based on reviews from: FDA.report, Olea Medical & RedBrick AI, Olea Medical Urgent Care, Radiology Key, accessdata.fda.gov, PMC (Automated Assessment of the DWI-FLAIR Mismatch in Patients with Acute Ischemic Stroke: Added Value to Routine Clinical Practice), PMC (Are the current MRI criteria using the DWI-FLAIR mismatch concept for selection of patients with wake-up stroke to thrombolysis excluding too many patients?), ResearchGate (A systematic review of the performance of Artificial Intelligence for automated DWI/FLAIR mismatch evaluation on MRI in ischemic stroke), Reddit (r/neurology), Reddit (r/doctorsUK), Olea Medical (The Diffusion saga), Olea Medical (Predictive Imaging), Olea Medical (MR evolution), MDPI (Artificial Intelligence for Automated DWI/FLAIR Mismatch Assessment on Magnetic Resonance Imaging in Stroke: A Systematic Review), ResearchGate (Evaluation of a Volume and Intensity-based FLAIR Algorithm Developed to Assist in DWI-FLAIR Mismatch Assessment in Wake-up Stroke), Brainomix (Automated Assessment of DWI-FLAIR Mismatch to Predict Stroke-onset Time), PubMed (DWI-FLAIR mismatch for the identification of patients with acute ischaemic stroke within 4u00b75 h of symptom onset (PRE-FLAIR): a multicentre observational study), PMC (DWI u2013 FLAIR Mismatch in Nocturnal Strokes Patients with Unknown Time of Onset), Reddit (r/Radiology), Vascular and Endovascular Review, Reddit (How accurate is this dumbed down explanation of DWI & ADC in acute/old stroke?)

Last updated: 2026-07-21

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Press & Coverage

GlobalData
Olea Medical receives 510(k) clearance for MR DWI/FLAIR Measurement V1.0
Olea Medical received 510(k) clearance from the FDA for its MR DWI/FLAIR Measurement V1.0 on May 11, 2023. This clearance is listed within a report on Medical Imaging Information Systems Pipeline.
2023-05
FDA.report / X-ray Interpreter
MR DWI/FLAIR Measurement V1.0 | FDA Radiology AI Device
MR DWI/FLAIR Measurement V1.0 is medical image processing software by Olea Medical that analyzes MRI brain images from diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR) sequences. It automatically computes diffusion maps and extracts relevant metrics to assist medical professionals in evaluating brain conditions.
2023-04
FDA.report
April 26, 2023 Olea Medical John J. Smith Partner Hogan Lovells US LLP Columbia Square, 555 Thirteenth Street, NW WASHINGTON - FDA.report
This document details the FDA 510(k) clearance for Olea Medical's MR DWI/FLAIR Measurement V1.0, indicating its intended use for analyzing MR Diffusion-weighted imaging (DWI) and MR FLAIR images. The device is intended to be used by trained professionals in conjunction with other patient information.
2023-04
Olea Medical
SOLUTION - Olea Medical
Olea Medical highlights MR DWI/FLAIR Measurement V1.0 as a Class IIa medical device in Europe and Class II in the US, designed to assist neuroradiologists by integrating advanced AI-driven detection and quantification into PACS. The solution aims to improve patient care by transforming CT and MR datasets into actionable insights.
unknown
Innolitics
MRI radiology AI tools | FDA-cleared directory
Olea Medical's MR DWI/FLAIR Measurement V1.0 is listed in an FDA-cleared directory of MRI radiology AI tools, with a decision date of April 26, 2023. It is categorized under image analysis/processing for MRI workflow.
2023-04
Innolitics
Command Line as a Medical Device (CLaMD) - Innolitics
This article mentions Olea Medical's MR DWI/FLAIR Measurement V1.0 in the context of medical devices that may not have a direct graphical user interface, stating that it needs to communicate with a technical platform to visualize outputs.
2025-05
Olea Medical
Urgent care - Olea Medical
Olea Medical's urgent care solutions include MR DWI/FLAIR Measurement V1.0, which assists radiologists and surgeons in imaging assessment by extracting and communicating key volumes of interest and indexes. It focuses on identifying hypointense zones on ADC maps and projecting them onto FLAIR maps.
unknown
accessdata.fda.gov
TPLC - Total Product Life Cycle - accessdata.fda.gov
The FDA's Total Product Life Cycle database lists Olea Medical S.A.S. and its MR DWI/FLAIR Measurement V1.0 with the 510(k) number K230552.
2026-07

Videos

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Frequently Asked Questions

AI tools can rapidly analyze MR DWI/FLAIR images to detect acute infarcts, identify large vessel occlusions (LVOs), and assess DWI/FLAIR mismatch, which is crucial for determining stroke onset time and treatment eligibility, especially in wake-up stroke patients. These tools aim to expedite diagnosis, reduce time to treatment, and improve workflow efficiency, particularly in settings without immediate access to stroke specialists.
AI tools for medical imaging, including DWI/FLAIR analysis, typically require regulatory clearances such as FDA 510(k) in the US and CE marking in Europe. Key ethical considerations include ensuring data privacy (e.g., HIPAA/GDPR compliance), addressing potential biases in AI training data that could lead to disparities, and maintaining transparency and explainability of AI decisions to foster trust and accountability.
The primary alternative is manual interpretation by neuroradiologists, which can sometimes have suboptimal inter- and intra-observer agreement for DWI/FLAIR mismatch assessment. AI-powered solutions aim to standardize this process, potentially offering faster analysis and consistent performance, with some studies showing AI performing comparably or even better than human experts in binary classifications of stroke onset time. Additionally, AI can generate synthetic FLAIR images from DWI, potentially shortening MRI scan times.
The cost of implementing AI in medical imaging can range from $150,000 to $500,000, with additional significant costs ($100,000-$500,000+) for regulatory pathways. Pricing models often involve pay-per-analysis or subscription fees, with some cloud-based solutions starting around u20ac5,000. Economic value is assessed through potential cost savings from improved efficiency, reduced treatment times, and enhanced patient outcomes, with some studies projecting substantial returns on investment over several years.
Current limitations of AI in DWI/FLAIR analysis include potential for missing smaller lesions or infarcts with low ADC signals, and sometimes modest predictability of lesion volume. The 'black-box' nature of some AI models can also limit transparency and explainability of their decisions, and the accuracy of these models heavily relies on large, diverse, and high-quality training datasets. AI tools are intended to assist, not replace, comprehensive patient evaluation and physician judgment.
Ensuring patient data privacy and security is paramount, requiring AI solutions to comply with regulations like HIPAA and GDPR. This involves robust data protection mechanisms, secure cloud infrastructure, and strict governance protocols for data sharing with AI companies. Transparency with patients about how their data is used is also crucial to maintain trust.
AI is not expected to replace radiologists but rather to augment their capabilities by automating time-intensive tasks and providing decision support. Physicians remain essential for final diagnosis, clinical correlation, and ensuring patient safety, as AI tools are cleared to assist clinicians and should not be used as primary diagnostic tools or relied upon solely for diagnosis. There are also concerns among physicians about potential skill loss with increased AI reliance.

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