{"product_name":"Neurophet AQUA","company_name":"Neurophet","product_url":"https://neurophet.com/Products/AQUA","company_url":"https://neurophet.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0138","summary":"Neurophet AQUA is an AI-powered software that analyzes brain MRI scans to assist in diagnosing and monitoring neurodegenerative diseases, including Alzheimer's and multiple sclerosis.","description":"Neurophet AQUA utilizes artificial intelligence to analyze brain MRI scans, providing rapid segmentation and analysis of brain images within five minutes. It quantifies brain volume and white matter hyperintensities (WMH), aiding in the diagnosis and prognosis assessment of neurodegenerative diseases such as Alzheimer's and multiple sclerosis. The software offers automated brain segmentation, atrophy pattern analysis by brain region, brain atrophy percentile analysis, and automated inter-operation with PACS. It is FDA-cleared, CE-marked, and approved in multiple countries, including Korea, Japan, and Singapore.","categories":["clinical Care","diagnostic Support","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","chronic Care Management","medical Device","regulatory Compliance","Clinical","Diagnostic","Medical Imaging","Artificial Intelligence","Neurodegenerative Diseases","Multiple Sclerosis","Alzheimer's Disease","Medical Device","Fda-cleared","Ce-marked"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Radiologists","Neurologists","Researchers","Healthcare Providers"],"specialties":["Neurology","Radiology","Neurodegenerative Diseases","Multiple Sclerosis","Alzheimer's Disease"],"regions_available":["United States","South Korea","Japan","Singapore","European Union","Other Countries with CE Marking"],"languages_supported":["English","Korean","Japanese","Chinese","Other Languages as Supported by CE Marking"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["South Korea","United States","Japan","Singapore","European Union"],"company_founding":"2016","deployment_model":["on_prem"],"os_platforms":["Windows"],"features":["Automated brain MRI segmentation (multiple regions including hippocampus)","Volume quantification per brain region","White matter hyperintensity (WMH) quantification","Lesion quantification (MS-focused features)","Multi-time-point / longitudinal analysis","Normative comparison with Asian and Western reference datasets","Configurable report generation with reference statistics","Color-coded segmentation overlays (DICOM output)","Radar-chart atrophy pattern visualization for subtype differentiation","Fast processing (typical 1–10 minutes per study)","Pre-populated radiological reporting templates","Automatic labeling and visualization of segmentable structures"],"optional_modules":["AQUA AD (Alzheimer's / anti-amyloid treatment monitoring)","AQUA for MS (multiple sclerosis lesion analysis)"],"integrations":["PACS / standard radiology reading environment"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"","compliance":["US FDA 510(k) cleared","CE (MDD)","MFDS (Korea)","MHLW (Japan)","HAS (Singapore)","TFDA (Thailand)"],"certifications":["FDA 510(k)","CE (MDD)","MFDS (Korea)","MHLW (Japan)","HAS (Singapore)","TFDA (Thailand)"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA","DLP"],"privacy_features":["BAA available","consent mgmt","anonymization","data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0138","slug":"neurophet-aqua","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/neurophet-aqua.json"}}