MR DWI/FLAIR Measurement
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
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 |
| Deployment | On-premise (PACS software module), Cloud Hosted, Web-Based |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown 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: PositiveStrengths
- 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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