{"product_name":"BrainSee","company_name":"Darmiyan","product_url":"https://darmiyan.com/products/","company_url":"https://darmiyan.com","related_urls":["https://www.prnewswire.com/news-releases/darmiyan-receives-fda-approval-for-post-market-surveillance-study-of-brainsee-the-first-in-class-clinical-test-for-predicting-risk-of-progression-to-clinical-alzheimers-disease-302468072.html","https://www.mcra.com/news-publications/case-studies/mcra-supports-darmiyan-fda-approval-brainsee-device","https://openminds.com/market-intelligence/bulletins/darmiyan-launches-brainsee-platform-for-alzheimers-testing-risk-monitoring/","https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0270","summary":"BrainSee is an FDA-approved AI-powered software that predicts the likelihood of progression from amnestic mild cognitive impairment to Alzheimer's dementia within five years.","description":"BrainSee integrates brain MRI scans with cognitive test scores to generate a prognostic score, assisting physicians in evaluating the risk of Alzheimer's progression in patients with amnestic mild cognitive impairment (aMCI).","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","patients"],"specialties":["Neurology","Geriatrics","Psychiatry"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States"],"company_founding":"2016","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["Clinical test for predicting risk of progression to clinical Alzheimer's disease","Post-market surveillance study","FDA-approved device"],"optional_modules":[],"integrations":["FDA 510(k) approval"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 13485","ISO 14971"],"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":"SW0270","slug":"brainsee","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/brainsee.json"}}