{"product_name":"QyScore","company_name":"Qynapse","product_url":"https://qynapse.com/qyscore/","company_url":"https://qynapse.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0526","summary":"QyScore® is an AI-powered neuroimaging analysis platform designed to enhance the diagnosis and monitoring of central nervous system (CNS) diseases by providing automated, precise brain MRI analyses.","description":"QyScore® offers automated quantification of brain structures and lesions from MRI scans, facilitating early detection and monitoring of CNS diseases such as Alzheimer's, multiple sclerosis, and Parkinson's. The platform generates automated patient reports and integrates with existing clinical workflows, aiming to reduce image reading variability and segmentation errors by 89%. It is FDA-cleared and CE-marked, supporting both clinical routine and clinical trial applications.","categories":["clinical Care","diagnostic Support","administrative Operations","Clinical","Diagnostic","Administrative"],"market_segment":["enterprise","smb","consumer"],"target_users":["clinicians","radiologists","neurologists","researchers","patients"],"specialties":["Neurology","Radiology","Geriatrics","Psychiatry","Neurosurgery"],"regions_available":["United States","European Union","Canada","Australia","Japan","South Korea","China","India","Brazil","Mexico","South Africa","Russia","United Kingdom","Germany","France","Italy","Spain","Netherlands","Belgium","Sweden","Norway"],"languages_supported":["English","French","German","Spanish","Italian","Dutch","Swedish","Norwegian","Portuguese","Russian","Chinese","Japanese","Korean","Hindi","Arabic","Turkish","Polish","Czech","Hungarian","Romanian"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["France","United States","Germany","United Kingdom","Canada","Australia","Japan","South Korea","China","India"],"company_founding":"2015","deployment_model":["cloud-based","hybrid","on-premises","virtualized"],"os_platforms":["web-based"],"features":["Automated neuroimaging analysis","Quantification of neuroinflammation and neurodegeneration","Whole brain, white matter, grey matter by lobe, cerebellum analysis","White matter abnormalities detection","Brain substructures analysis","Automated patient report generation","3D visualization platform integration","Reduced image reading variability","Reduced segmentation errors","Enhanced precision and accuracy"],"optional_modules":["Ischemic Stroke analysis","Huntington’s Disease analysis","Epilepsy analysis","Traumatic Brain Injury analysis","Schizophrenia analysis","Depression analysis"],"integrations":["PACS","AI marketplace","distribution platform","stand-alone web-based"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"cloud-based, hybrid, on-premises, virtualized","compliance":["HIPAA","GDPR","ISO 27001","ISO 9001","CE Certification","FDA 510(k) clearance"],"certifications":["CE Certification","FDA 510(k) clearance","ISO 27001","ISO 9001"],"security_features":["end-to-end encryption","zero-trust architecture","privacy by design","SOC 2 Type II compliance","regular security assessments","penetration testing","multi-factor authentication","role-based access control","continuous monitoring","incident response planning"],"privacy_features":["data minimization","anonymization","pseudonymization","data residency compliance","user data control","data sharing controls"],"data_residency":"EU, US, other regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0526","slug":"qyscore","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/qyscore.json"}}