MR Diffusion Perfusion Mismatch

by Olea Medical  · Based in France →Improved diagnosis for life.
Interventional Radiology Neurology Radiology

Contact vendor for details
Regulatory Status Disclosed

Overview

Olea Medical’s MR Diffusion Perfusion Mismatch V1.0 is an intelligent, automated software solution designed for rapid and accurate post-processing of Magnetic Resonance (MR) imaging data, particularly crucial in acute ischemic stroke diagnosis. [1, 11, 14, 18, 22] This AI-driven tool seamlessly integrates into clinical workflows, providing instant qualitative and quantitative parameters to enhance collaboration and optimize evaluation methodology for various pathologies. [1, 4, 5, 18]

The software offers automated diffusion-perfusion mismatch analysis, which is vital for identifying the infarct core and penumbra in stroke patients, aiding in critical treatment decisions. [11, 14, 15, 18, 22, 25] It provides quantitative analysis of hypoperfused tissue volume, ADC lesion volume, and DWI-FLAIR volumes mismatch. [1, 14, 18, 22] Built on proprietary Bayesian algorithms and advanced optimization methods, Olea Medical’s solutions are recognized for their speed, stability, and efficacy, transforming MR and CT datasets into clear, actionable insights within a unified workflow. [4, 5, 8, 17, 18]

Key functionalities include no-click access to quantitative information, CBV corrected and permeability maps computation, ADC mapping, and structured reporting with automatic export to PACS and email. [1, 4, 18] The system is vendor-neutral, compatible with a wide range of MR and CT scanners, and supports an enhanced intuitive workflow. [1, 5, 6, 19, 20] A dedicated mobile application further supports neuroradiologists by delivering real-time alerts, notifications, and patient image overviews, enabling faster and more consistent decisions in time-sensitive emergency settings. [4, 18]

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated Diffusion-Perfusion Mismatch analysis
  • Quantitative analysis of stroke parameters (e.g., hypoperfused tissue volume, ADC lesion volume)
  • Fast and accurate image processing
  • Seamless integration into clinical workflows (PACS, email)
  • Vendor-neutral compatibility with MR and CT scanners
  • AI-driven detection, quantification, and structured reporting
  • Dedicated mobile application for real-time alerts and image overview
  • Proprietary Bayesian algorithms for improved signal processing
  • DWI-FLAIR volumes mismatch assessment for infarct dating
  • Automated restrictive diffusion and threshold-based hypo-perfused volume extraction

Use Cases

  • Acute ischemic stroke diagnosis and treatment decision support
  • Neurovascular emergency solutions for rapid triage
  • Brain tumor diagnosis and assessment (as part of broader Olea solutions)
  • Optimizing clinical productivity and radiology workflow
  • Longitudinal analysis and response-to-treatment assessment
  • Functional brain connectivity assessments (related to broader neuro imaging capabilities)

What Physicians Need to Know

Stroke Detection Speed
Automatically generates stroke maps in seconds, providing a rapid and reliable tool for stroke detection. Automates lesion segmentation, volume calculation, and perfusion mapping to significantly speed up decision-making, which is crucial for improving neurological recovery. The Automation Platform V1.5 prioritizes and triages clinical cases in real-time.
Brain MRI/CT Analysis
Offers multi-vendor post-processing solutions for MRI and CT images, focusing on Diffusion-weighted Imaging (DWI) and Perfusion-weighted Imaging (PWI) to identify areas of restricted water movement and reduced blood flow. Automates lesion segmentation, volume calculation, and perfusion mapping, including sequence fusion, enhanced contrast, and subtle anomaly detection. Performs Diffusionu2013Perfusion analysis with mismatch assessment and automated restrictive diffusion and hypoperfused volume extraction. The MR Clinical Suite, powered by Olea Medical, provides streamlined Diffusion and Perfusion workflows.
Large Vessel Occlusion Detection
Enables rapid triage of large vessel occlusions (LVOs) and hemorrhages within seconds. Includes AI-driven LVO detection for anterior circulation (Distal ICA, M1 & Proximal M2) on CT imaging. AI algorithms automatically detect anomalies and send alerts to specialists, reducing management time.
Triage Prioritization Speed
The Automation Platform V1.5 prioritizes and triages clinical cases in real-time, with automatic reports instantly sent to the radiologist's chosen tool (mobile, email, PACS). The Neurovascular Solution is designed for neuroradiologists under pressure, integrating AI-driven detection, quantification, and structured reporting for faster, more consistent decisions.
ASPECTS Score Automation
Provides AI-based ASPECTS hypodensity probability heat maps for CT imaging. Post-processing software accurately measures lesions using the Alberta Stroke Program Early CT Score (ASPECTS). The e-STROKE SUITE, a collaboration, incorporates e-ASPECTS.
Mobile Notification System
Features a dedicated mobile application that delivers real-time alerts, notifications, and patient image overviews. Automatic reports can be sent to a mobile phone. Olea Medical partners with telehealth specialists like Pulsara to offer mobile applications for streamlined neurovascular care coordination and communication among stroke teams.
Physician Tip

Leverage Olea Medical's MR Diffusion Perfusion Mismatch tool for rapid, objective, and standardized assessment of acute ischemic stroke. Focus on utilizing the automated lesion segmentation, volume calculation, and perfusion mapping to quickly identify the ischemic penumbra and differentiate it from the necrotic core, which is critical for timely therapeutic decision-making regarding thrombolysis or thrombectomy. The tool can assist in personalizing treatment strategies, even for patients presenting beyond standard timeframes. Integrate the automated reports and mobile notifications into your workflow to enhance communication and accelerate patient management, ultimately improving patient outcomes.

Olea Medical's solutions are designed as multi-vendor post-processing tools compatible with various MRI and CT scanners. The Neurovascular Solution seamlessly integrates AI-driven detection and reporting directly into Picture Archiving and Communication Systems (PACS). Automated, customizable reports can be exported to PACS and via email. Strategic partnerships, such as with Brainomix for the e-STROKE SUITE and Pulsara for mobile neurovascular care applications, further enhance workflow integration and communication within stroke care networks.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Contact vendor for details Not publicly available
DeploymentOn-premise or thin-client deployment; contact vendor for specific cloud options and integration details. [19, 20]
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

MR Diffusion Perfusion Mismatch V1.0 received 510(k) clearance (K223502) from the U.S. FDA on January 13, 2023. It is classified under regulation 21 CFR 892.2050 (Medical image management and processing system) with product code LLZ and was determined substantially equivalent to the predicate device Olea Sphere V3.0 (K152602). [12, 16]

Integrations
EHR Not specified
Specialties Interventional Radiology, Neurology, Radiology

What the Web Says

MR Diffusion Perfusion Mismatch, particularly as implemented in Olea Medical's Olea Sphereu00ae software, is a tool used by physicians to assess acute ischemic stroke patients and identify salvageable brain tissue (penumbra). The software automatically calculates core, penumbra, and mismatch ratios using MR diffusion and perfusion images, aiding in timely treatment decisions. While considered a cornerstone of modern medical imaging for neurological disorders and increasingly for other body illnesses like cancer, there are noted discrepancies in volume estimations when comparing different software packages.

Overall: Mixed

Strengths

  • Provides automated calculation of infarct core, penumbra, and mismatch ratio, which is crucial for rapid decision-making in acute ischemic stroke.
  • Aids in selecting patients for treatments like mechanical thrombectomy by applying inclusion and exclusion criteria from clinical trials.
  • Offers robust and efficient software solutions for the healthcare community, built upon diffusion MRI and IVIM MRI.
  • Can be reviewed directly within local PACS systems, on mobile devices, or via a web-based interface, providing flexibility for physicians.
  • Utilizes advanced techniques like Bayesian post-processing, which has shown to outperform other methods for reduced-contrast-dose perfusion.
  • The concept of perfusion-diffusion mismatch is a qualitative marker for potential infarct expansion, helping to identify brain tissue at risk.

Limitations

  • Automated MRI perfusion-diffusion mismatch estimations can differ significantly between various software packages, potentially leading to different treatment decisions for individual patients.
  • Olea Sphereu00ae has been observed to estimate larger volumes for hypoperfused tissue and perfusion-diffusion mismatch compared to other software like RAPIDu00ae.
  • The concept of PDM does not always optimally define the ischemic penumbra, as early DWI abnormalities can overestimate the infarct core and PWI abnormalities can overestimate the penumbra.
  • MRI evaluation for acute ischemic stroke can be time-consuming and costly, with equipment limitations and patient-related challenges.
  • Mismatch alone does not consistently distinguish patients with good and poor prognoses, as both can have positive or negative outcomes.
  • Perfusion imaging can be more challenging for acute stroke patients compared to diffusion imaging.

Based on reviews from: The Diffusion saga - Olea Medical, Clock around the stroke | Olea Medical, Automated MRI perfusion-diffusion mismatch estimation may be significantly different in individual patients when using different software packages - PMC, MRI software for diffusion-perfusion mismatch analysis may impact on patients' selection and clinical outcome - PMC, (PDF) Automated MRI perfusion-diffusion mismatch estimation may be significantly different in individual patients when using different software packages - ResearchGate, Magnetic resonance diffusion-perfusion mismatch in acute ischemic stroke: An update, Olea Medical touts clinical study | AuntMinnie, Olea Medical - Predictive Imaging, Comparison the Perfusion/Diffusion Mismatching Judging From CT-Based and MR-Based Study - Journal of Neurointensive Care, MRI software for diffusion-perfusion mismatch analysis may impact on patients' selection and clinical outcome - OUCI, Current concepts on magnetic resonance imaging (MRI) perfusion-diffusion assessment in acute ischaemic stroke: a review & an update for the clinicians - Indian Journal of Medical Research, Magnetic resonance diffusion-perfusion mismatch in acute ischemic stroke: An update, A practical assessment of magnetic resonance diffusion-perfusion mismatch in acute stroke: observer variation and outcome - PubMed, Oligo/Perfusion MRI : r/braincancer - Reddit, Automated MRI perfusion-diffusion mismatch estimation may be significantly different in individual patients when using different software packages - PubMed

Last updated: 2026-07-20

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Press & Coverage

accessdata.fda.gov
MR Diffusion Perfusion Mismatch V1.0 510(k) Summary
Olea Medical's MR Diffusion Perfusion Mismatch V1.0, an image processing application for PACS, was deemed substantially equivalent to its predicate device, Olea Sphereu00ae V3.0, by the FDA in January 2023. This regulatory filing details the device's intended use, technological characteristics, and validation testing, confirming its safety and effectiveness for use in radiology.
2023-01
X-ray Interpreter
MR Diffusion Perfusion Mismatch V1.0 | FDA Radiology AI Device
Olea Medical's MR Diffusion Perfusion Mismatch V1.0 is an AI-powered software tool that automates the processing of MR Diffusion and Perfusion imaging data to generate parametric maps, extract volume metrics, and calculate mismatch volumes, aiding radiologists and surgeons in clinical decision-making.
2023-01
BEUDAMED
MR Diffusion Perfusion Mismatch V1.0 - BEUDAMED
This entry in the EUDAMED database provides information on MR Diffusion Perfusion Mismatch V1.0, a medical device manufactured by Olea Medical S.A.S. and regulated under the EU MDR.
unknown
British Journal of Radiology
Artificial intelligence in neuroradiology: a review of Food and Drug Administration-regulated algorithms
This peer-reviewed article reviews FDA-regulated AI algorithms in neuroradiology, listing Olea Medical's MR Diffusion Perfusion Mismatch as a tool for processing perfusion data in both CT and MR modalities, cleared on January 13, 2023.
2026-05
Innolitics
Command Line as a Medical Device (CLaMD)
This article discusses Command Line as a Medical Device (CLaMD) and references Olea Medical's MR Diffusion Perfusion Mismatch V1.0 (K223502) as an example of a software that operates without a direct user interface, relying on a technical platform for output visualization.
2025-05
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
This guide on AI/ML SaMD ground truthing cites Olea Medical's MR Diffusion Perfusion Mismatch V1.0 (K223502) to illustrate how qualitative assessments by board-certified neuroradiologists were used to establish substantial equivalence for parametric maps and volume measurements.
2025-09
MedicalExpo
Automation Platform Brochure EN - Olea Medical
Olea Medical's 'Automation Platform' brochure highlights MR Diffusion Perfusion Mismatch v1.0 as one of its applications within the AutoNeurovascular solution, designed to optimize hospital workflow for acute neurovascular exams by providing automatic mismatch calculations between extracted volumes.
unknown

Videos

Product demos, reviews, and walkthroughs for MR Diffusion Perfusion Mismatch.

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Frequently Asked Questions

AI algorithms analyze diffusion-weighted imaging (DWI) and perfusion-weighted imaging (PWI) data to automatically identify and quantify the mismatch between the ischemic core and the penumbra in acute stroke patients. This real-time analysis helps guide urgent treatment decisions, such as mechanical thrombectomy, by providing rapid and objective information on salvageable brain tissue, potentially improving patient outcomes and reducing recurrent vascular events.
AI tools in healthcare must comply with stringent regulations like HIPAA in the US and GDPR in Europe, which govern patient data protection and privacy. Additionally, AI software used for diagnosis or treatment guidance often requires FDA clearance or CE marking as a medical device, necessitating rigorous validation and adherence to quality management systems like ISO 13485.
Non-AI methods primarily involve manual interpretation and volumetric assessment of DWI and PWI by radiologists and neurologists, which can be time-consuming and subject to inter-reader variability. AI solutions offer significantly faster processing times, often providing mismatch information within minutes, and have demonstrated high sensitivity and specificity comparable to or exceeding manual methods in identifying the mismatch.
The cost for integrating AI solutions in medical imaging can vary widely, with diagnostic and imaging AI systems typically ranging from $200,000 to $800,000, including specialized hardware, software licensing, and integration. Pricing models often include annual subscription fees, which for MRI AI solutions can be between $100,000 and $200,000, or a pay-per-analysis model.
AI models can be limited by a lack of clinical context, potential for false positives or negatives, and difficulties in distinguishing clinically significant findings from insignificant ones. Their performance can also be affected by image artifacts, suboptimal acquisition, and a lack of generalizability if trained on limited or biased datasets, potentially leading to misinterpretations in atypical cases.
AI is currently considered a powerful decision support tool that augments, rather than replaces, human expertise in diagnosing MR Diffusion Perfusion Mismatch. While AI can rapidly process images and highlight potential mismatches, human radiologists provide crucial clinical context, integrate patient history, and exercise judgment, especially in complex or ambiguous cases.
AI solutions ensure patient data security through robust technical safeguards like encryption, secure data storage, access controls, and audit logging, often leveraging cloud security measures. Compliance with medical device regulations involves rigorous validation, documentation traceability, risk management processes, and post-market monitoring, as mandated by bodies like the FDA, to ensure the software's safety and effectiveness.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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