QyScore

by Qynapse  · Based in Canada → — The future of neuroimaging is here.
Neurology Radiology
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Regulatory Status Disclosed

Overview

Qynapse is a medical technology company dedicated to advancing the accuracy and reliability of Central Nervous System (CNS) disease screening and monitoring. Founded in Paris, France in 2015, as a spin-off from the CATI consortium of neuroimaging research laboratories, Qynapse aims to bring groundbreaking technology to the global fight against CNS disorders.

Its flagship solution, QyScore®, is an AI-powered and proprietary neuroimaging software platform designed to provide physicians, pharma researchers, and payers with an objective layer of precision when making a CNS disease diagnosis. QyScore® produces a wide range of automated neuroimaging biomarkers to assist physicians in making clinical care decisions and monitoring patients over time. The platform is utilized in both clinical routine settings and clinical trial applications, supporting the diagnosis, prognosis, and drug efficacy measurement for various CNS diseases.

QyScore® is FDA-Cleared and CE-Marked, demonstrating superior performance compared to certain other automated state-of-the-art methods and validated against gold-standard manual segmentation. It integrates seamlessly with existing clinical workflows, providing rapid, actionable insights for objective brain scan analysis.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated segmentation and volumetric quantification of brain structures and lesions
  • Comparison of patient's brain metrics to a large normative database of healthy subjects
  • Rapidly generated automated patient reports
  • Proprietary and integrated 3D visualization platform
  • Decreases image reading variability and segmentation errors by 89%
  • Compatible with routine clinical workflow and integrates with PACS, AV, AI viewers
  • Supports 1.5T and 3T MRI scanners for T1 MRI processing, and 3T for T2FLAIR MRI
  • Automated measures of neuroinflammation and neurodegeneration
  • Longitudinal charts and 3D rendering for atrophy and disease activity assessment
  • Vendor-neutral and compliant with gold standard brain MRI protocols (ACR, ADNI, OFSEP)

Use Cases

  • Support timely diagnosis of CNS diseases
  • Disease and therapy monitoring
  • Support tailored treatment plans and facilitate therapeutic switching
  • Enhance clinical trial design and improve patient selection
  • Measure drug efficacy and safety in clinical trials
  • Objective brain scan analysis for neurodegenerative disorders

What Physicians Need to Know

Brain MRI Analysis
QyScore provides automated segmentation and volumetric quantification of brain structures (e.g., whole brain, white matter, grey matter by lobe, hippocampus, amygdala, white matter hyperintensities) from 3DT1 and FLAIR MRI images. It quantifies markers for neurodegenerative diseases, compares results to a healthy subject database, and generates automated patient reports rapidly. The software reduces image analysis time and cost by approximately 80% and decreases image reading variability and segmentation errors by 89%. It is FDA-cleared and CE-marked.
Neurodegenerative Disease Screening
QyScore is a core tool for the early diagnosis and clinical monitoring of neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, and multiple sclerosis. It quantifies key markers such as brain atrophy and white matter hyperintensities, comparing them to a large normative database of healthy subjects to support timely diagnosis and progression monitoring.
Triage Prioritization Speed
The software delivers analysis results and automated patient reports rapidly, often within minutes, contributing to faster clinical decision-making. It aims to reduce overall image analysis time and cost by approximately 80%.
Stroke Detection
Ischemic Stroke detection is listed as 'In Development' for QyScore.
Seizure Detection
Epilepsy is listed as 'In Development' for QyScore.
Physician Tip

QyScore offers objective and precise neuroimaging data, reducing inter- and intra-rater variability in image reading. This supports timely and more accurate diagnosis, facilitates disease and therapy monitoring, and aids in developing tailored treatment plans for patients with CNS diseases like Alzheimer's, MS, and Parkinson's. The rapid generation of automated reports and comparison to a healthy normative database enhances clinical decision confidence and can promote earlier intervention.

QyScore is a cloud-based platform designed for seamless integration into existing clinical workflows, supporting PACS, AV, and AI viewers. It is vendor-neutral for MRI systems, PACS, and viewers, and integrates through DICOM protocols and standards, including DICOM SR, FIHR standards, and DICOM SEG. Deployment options include stand-alone web-based, cloud-based, hybrid solutions, or locally on dedicated hardware.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentCloud-based, Hybrid solution, Locally on dedicated hardware, Locally virtualized (virtual machine, Docker)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

QyScore® received U.S. Food and Drug Administration (FDA) 510(k) clearance (K192531) on December 13, 2019. It is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from a set of MR images, with volumetric data comparable to reference percentile data.
Integrations
EHR Not specified
Specialties Neurology, Radiology

What the Web Says

QyScore, developed by Qynapse, is an FDA-cleared and CE-marked neuroimaging analysis platform designed for both clinical routine and clinical trials. It automates the measurement of neuroinflammation and neurodegeneration markers from MRI scans, aiming to provide more accurate and timely diagnoses and monitoring for neurological diseases like Alzheimer's, Parkinson's, and multiple sclerosis. The platform generates automated patient reports and offers a 3D visualization platform for physicians. Studies suggest it significantly reduces image reading variability and segmentation errors, demonstrating better performance than some other automated methods.

Overall: Positive

Strengths

  • Decreases image reading variability and segmentation errors by 89%.
  • Provides reliable automatic segmentation of brain structures.
  • Generates automated patient reports and offers 3D visualization.
  • Supports timely diagnosis and monitoring of disease progression.
  • Cloud-based, easy to use, and scalable.
  • FDA-cleared and CE-marked, suitable for clinical trials and routine.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • The search results did not include independent tech reviews, Reddit discussions, or detailed user reviews from G2 or Capterra specifically for QyScore, making it difficult to identify potential drawbacks from those sources.

Based on reviews from: Qynapse (qynapse.com), PubMed (Validation of an automatic tool for the rapid measurement of brain atrophy and white matter hyperintensity: QyScoreu00ae), NeurologyLive (FDA Clears QyScore Imaging Software for CNS Diseases), AuntMinnie (FDA clears Qynapse's brain MRI analysis software), MedicalExpo (Medical software - QyScoreu00ae - qynapse - hospital / image analysis / reporting), Parkinson's News Today (Imaging Analysis Software QyScore Receives FDA Clearance)

Last updated: 2026-07-21

Ratings & Reviews

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Press & Coverage

PR Newswire
Qynapse Releases Data Highlighting the Accuracy of QyScoreu00ae and Predictive performance of QyPredictu00ae for Disease Progression in preclinical Alzheimer's Disease
Qynapse presented new data at the Alzheimer's Association International Conference (AAIC) for QyScoreu00ae and QyPredictu00ae, demonstrating QyScoreu00ae's higher segmentation accuracy and reliability over other established products for key brain regions. QyPredictu00ae also showed accuracy in identifying patients with preclinical AD and mild cognitive impairment (MCI) likely to experience cognitive decline over 24 months.
2025-07
Canada Newswire
Qynapse to present new evidence on the value of QyScoreu00ae for the diagnosis and monitoring of multiple sclerosis at ACTRIMS Forum 2022
Qynapse Inc. announced it would present two posters at the ACTRIMS Forum 2022, highlighting QyScoreu00ae's reproducibility and its value in informing MS diagnostic standards. The presentations also covered the high performance of QyScoreu00ae for automated quantification of white matter hyperintensities.
2022-02
PubMed (European Radiology)
Validation of an automatic tool for the rapid measurement of brain atrophy and white matter hyperintensity: QyScoreu00ae
This peer-reviewed article validates QyScoreu00ae as a reliable medical device for automatic segmentation of brain structures, including grey and white matter, hippocampus, amygdala, and white matter hyperintensity. The study found QyScoreu00ae performed reliably compared to expert neuroradiologists, supporting its use in clinical trials and routine for neurological disease diagnosis and monitoring.
2022-01
Alzheimer's & Dementia
QyScoreu00ae MRI markers' diagnostic accuracy in the clinical spectrum of Alzheimer's disease
This publication assesses the diagnostic accuracy of QyScoreu00ae medial temporal lobe atrophy markers in differentiating AD dementia and Mild Cognitive Impairment (MCI) individuals from healthy controls in US and EU cohorts.
2021-12
BioSpace
Qynapse to present clinical results of QyScoreu00ae for Alzheimer's Disease and Multiple Sclerosis at the 7th Congress of the European Academy of Neurology
Qynapse Inc. announced it would present clinical data on QyScoreu00ae for Alzheimer's disease and multiple sclerosis at the 7th Congress of the European Academy of Neurology. The platform provides automated quantification of neurodegenerative and neuroinflammatory markers.
2021-06
NeurologyLive
FDA Clears QyScore Imaging Software for CNS Diseases
The FDA has cleared QyScore software for analyzing brain MRI markers in neurodegenerative diseases like Alzheimer's, Parkinson's, and multiple sclerosis. The software, developed by Qynapse, provides rapid analysis and compares results to a database of healthy subjects.
2020-02
Multiple Sclerosis News Today
QyScore, Imaging Software that Analyzes MRI Markers of Brain Disease, Earns FDA Clearance
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for QyScore, a cloud-based imaging software for automated quantification of key MRI markers of central nervous system disease. This software standardizes image analysis, reduces variability, and provides rapid, reliable results.
2020-02
Qynapse (Press Release)
Qynapse receives FDA clearance for QyScoreu00ae, a novel imaging software for central nervous system diseases
QYNAPSE announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its QyScoreu00ae software. QyScoreu00ae offers precise analyses of brain MRI markers crucial for early diagnosis and clinical monitoring of neurodegenerative diseases.
2020-02

Videos

Product demos, reviews, and walkthroughs for QyScore.

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Frequently Asked Questions

QyScore is designed to integrate seamlessly into existing clinical workflows, including PACS and AI viewers, and can be deployed as a cloud-based, hybrid, or local solution. It provides automated analysis of brain MRI markers to support the diagnosis and monitoring of central nervous system diseases such as Alzheimer's disease, Multiple Sclerosis, and Parkinson's disease.
QyScore is FDA 510(k) cleared (Class II) in the U.S. and CE-marked (Class IIa) in Europe, indicating its compliance with medical device regulations. Qynapse, the developer, states that it is HIPAA Compliant, GDPR Compliant, and 21 C.F.R. Part 11 Compliant to ensure patient data privacy and security.
While QyScore provides robust analysis, its current FDA indications for use specify it is not intended for clinical scenarios requiring evaluation of the *number* of white matter hyperintensities. Additionally, while validated, some studies note that the GM segmentation algorithm was not initially optimized for excluding white matter lesions, requiring review of results.
QyScore has demonstrated superior performance compared to certain other automated state-of-the-art methods like FreeSurfer, FSL, and ANTs for segmenting various brain structures. It also aims to decrease image reading variability and segmentation errors by standardizing analysis, which is a significant improvement over time-consuming and subjective manual segmentation.
QyScore operates on a subscription-based pricing model. The cost is typically based on factors such as the number of installations required for a practice or hospital. Specific pricing details usually require direct inquiry with Qynapse or its resellers.
QyScore has been validated against gold-standard manual segmentation and has shown strong concordance with expert neuroradiologist consensus for various brain volumes. It aims to decrease image reading variability and segmentation errors by 89%, providing precise and accurate automated measures of neuroinflammation and neurodegeneration.
While specific training programs are not detailed in the search results, QyScore is designed with an advanced user interface that generates automated patient reports to facilitate review by physicians. The company, Qynapse, emphasizes accelerating collaboration with experts and healthcare providers, suggesting support and resources are available for users.

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