JSON twin: https://www.healthaidb.com/software/qyscore.json
Qynapse
QyScore is a cloud-based, FDA-cleared and CE-marked neuroimaging software that automatically segments, labels and provides volumetric quantification of brain structures to support diagnosis and monitoring of CNS diseases.
QyScore (Qynapse) is a proprietary medical device software platform that performs fully automated, high-resolution MRI segmentation, volumetry and visualization for central nervous system structures and lesions. It generates automated patient reports, includes QC and preprocessing for clinical and clinical-trial use, and is deployed as a cloud-based solution designed for routine care, research and trial workflows. It is FDA-cleared (Class II) and CE-marked (Class IIa) with documented performance versus other tools and ISO/IEC/21 CFR and privacy compliances.
unknown
2015
Global cloud hosting with regional offices (France, USA, Canada); HDS-certified hosting option (France) available
P2024
2025-09-07
Commercial proprietary
Contact vendor for pricing, deployment and trial/demo information.
enterprise_quote
2020
Modern web browser; DICOM connectivity to PACS/DICOM server; internet access for cloud service
product
1.0
{
"company_name": "Qynapse",
"company_url": "https://qynapse.com/",
"company_offices": [
"France",
"United States",
"Canada"
],
"company_founding": "2015",
"product_url": "https://qynapse.com/qyscore/",
"categories": [
"clinical",
"diagnostic",
"imaging",
"neuroimaging",
"decision support",
"research",
"clinical trials"
],
"market_segment": [
"enterprise",
"research",
"healthcare providers",
"pharma"
],
"links": [
"https://qynapse.com/qyscore/",
"https://qynapse.com/",
"https://qynapse.com/company/",
"https://manuals.qynapse.com/",
"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192531",
"https://healthairegister.com/products/qynapse-qyscore",
"https://www.prnewswire.com/news-releases/qynapse-receives-fda-clearance-for-qyscore-a-novel-imaging-software-for-central-nervous-system-diseases-300997612.html",
"https://www.biospace.com/b-qynapse-b-receives-ce-mark-for-qyscore-cloud-based-solution-for-automatic-extraction-quantification-and-comparison-to-normative-dataset-of-imagi/"
],
"summary": "QyScore is a cloud-based, FDA-cleared and CE-marked neuroimaging software that automatically segments, labels and provides volumetric quantification of brain structures to support diagnosis and monitoring of CNS diseases.",
"description": "QyScore (Qynapse) is a proprietary medical device software platform that performs fully automated, high-resolution MRI segmentation, volumetry and visualization for central nervous system structures and lesions. It generates automated patient reports, includes QC and preprocessing for clinical and clinical-trial use, and is deployed as a cloud-based solution designed for routine care, research and trial workflows. It is FDA-cleared (Class II) and CE-marked (Class IIa) with documented performance versus other tools and ISO/IEC/21 CFR and privacy compliances.",
"target_users": [
"radiologists",
"neurologists",
"clinicians",
"researchers",
"pharma clinical trial teams",
"payers",
"imaging scientists",
"neuroimaging-trained personnel",
"clinical site technicians",
"IT/admins"
],
"specialties": [
"Alzheimer's disease / dementia",
"multiple sclerosis",
"Parkinson's disease / movement disorders",
"neurodegeneration",
"neuroinflammation",
"ischemic stroke (in development)",
"Huntington's disease (in development)",
"epilepsy (in development)",
"traumatic brain injury (in development)",
"psychiatry: schizophrenia, depression (in development)"
],
"regions_available": [
"United States",
"European Union",
"France",
"Canada",
"Global (select markets)"
],
"languages_supported": [
"English",
"French"
],
"pricing_model": "enterprise_quote",
"pricing_details": "Contact vendor for pricing, deployment and trial/demo information.",
"license": "Commercial proprietary",
"deployment_model": [
"cloud (SaaS)",
"web-based"
],
"os_platforms": [
"Web (modern browser)"
],
"features": [
"automated volumetric segmentation of brain structures",
"quantification of whole brain, lobes, cerebellum, WM/GM, WMH",
"automated patient report generation (downloadable)",
"3D visualization/renderer of segmentations",
"longitudinal comparison and trend graphs",
"pre-processing and automated quality control",
"volume percentile comparison to reference dataset",
"ROI opacity and window/level controls",
"CSV report export",
"user feedback / QC annotation workflow"
],
"optional_modules": [
"clinical-trial workflow / batch processing",
"longitudinal analysis module"
],
"integrations": [
"PACS / DICOM server",
"on-prem DICOM archive",
"site-specific HL7 interface (for IT integration)"
],
"data_standards": [
"DICOM",
"HL7 v2"
],
"api_available": "unknown",
"system_requirements": "Modern web browser; DICOM connectivity to PACS/DICOM server; internet access for cloud service",
"compliance": [
"HIPAA compliant",
"GDPR compliant",
"21 C.F.R. Part 11 compliant"
],
"certifications": [
"FDA cleared (510(k))",
"CE marked (CE2797)",
"ISO 13485",
"ISO/IEC 27001",
"HDS (France health data hosting)"
],
"security_features": [
"ISO/IEC 27001-aligned security controls",
"audit logging (user actions and reports)",
"encrypted data transfer (TLS)"
],
"privacy_features": [
"HIPAA compliance / BAA available",
"GDPR compliance"
],
"data_residency": "Global cloud hosting with regional offices (France, USA, Canada); HDS-certified hosting option (France) available",
"customers": [
"Pacific Brain Health Center / Pacific Neuroscience Institute",
"Pitié-Salpêtrière Hospital / Sorbonne University (research collaborators / advisors)",
"Tower Imaging Medical Group",
"UnitedHealthcare Specialty Benefits (represented by former CEO advisor)",
"University of Miami (research collaboration)"
],
"user_reviews": [],
"ratings": [
"FDA 510(k) clearance for QyScore® (FDA 2020)",
"CE marked (CE2797)",
"ISO 13485 certified",
"ISO/IEC 27001 certified",
"HIPAA compliant"
],
"support_channels": [
"email",
"documentation",
"contact form"
],
"training_options": [
"documentation (user manuals)",
"webinars",
"live_online (demos)"
],
"release_year": "2020",
"integration_partners": [
"Calyx",
"Blackford Analysis",
"University of Miami (research partner)"
],
"id": "P2024",
"slug": "qyscore",
"type": "product",
"version": "1.0",
"last_updated": "2025-09-07",
"links_json": {
"self": "https://www.healthaidb.com/software/qyscore.json"
}
}