{"product_name":"NeuroICH","company_name":"Neurocareai","product_url":"https://neurocareai.com","company_url":"https://neurocareai.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0133","summary":"NeuroICH is an AI-powered mobile application developed by NeuroCareAI to assist healthcare professionals in rapidly detecting intracranial hemorrhages (ICH) from non-contrast CT scans, thereby facilitating timely clinical decisions and improving patient outcomes in critical care scenarios.","description":"NeuroICH is an FDA-cleared mobile application designed to aid trained clinicians in the swift identification of suspected intracranial hemorrhages (ICH) by analyzing non-contrast CT images of the head. The app provides rapid, AI-driven analysis and notifies clinicians of potential ICH findings, enabling prompt clinical decisions and enhancing patient outcomes in critical care settings. It is intended solely as a notification tool and is not a diagnostic device; clinicians should rely on their clinical judgment and refer to hospital PACS or clinical systems for comprehensive case evaluation before making medical decisions. The app is available for free on the App Store and is compatible with iOS 12.0 or later devices. It is regulated as an FDA-cleared medical device intended for use by trained clinicians. The app is available in English and is free to download. The company, NeuroCareAI Inc., was founded in 2025 and has offices in the United States.","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","patients","admins"],"specialties":["Neurology","Emergency Medicine","Radiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"free","pricing_details":"Free to download on the App Store.","license":"commercial","company_offices":["United States"],"company_founding":"2025","deployment_model":["SaaS"],"os_platforms":["Web","iOS","Android"],"features":["AI-powered cerebral hemorrhage detection","Real-time analysis of non-contrast CT head images","Parallel workflow integration with standard care processes","Mobile application for image preview notifications","Non-diagnostic preview images for informational purposes","Global availability with free access in low- and middle-income countries","Not FDA-approved; unavailable for sale in the USA"],"optional_modules":[],"integrations":["RadioViewAI PACS system","Mobile application for image preview notifications"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","GDPR","SOC 2 Type II","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 13485"],"security_features":["Encryption","Role-Based Access Control (RBAC)","Single Sign-On (SSO)","Audit logs","Two-Factor Authentication (2FA)","Data Loss Prevention (DLP)"],"privacy_features":["Business Associate Agreement (BAA) availability","Consent management","Data anonymization","Data minimization"],"data_residency":"US/EU regions","customers":["Neurocareai"],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0133","slug":"neuroich","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/neuroich.json"}}