{"product_name":"ClarityPro AI","company_name":"Ceribell","product_url":"https://ceribell.com/product/claritypro/","company_url":"https://ceribell.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0351","summary":"ClarityPro AI by Ceribell is an AI-driven EEG diagnostic system designed for rapid detection and monitoring of electrographic status epilepticus in critically ill patients, enhancing timely and informed neurological care decisions.","description":"ClarityPro AI is an advanced machine-learning algorithm integrated into Ceribell's portable EEG system, providing continuous, real-time monitoring and analysis of EEG waveforms to detect and diagnose electrographic status epilepticus (ESE). It offers bedside alerts, seizure burden displays, and medication response monitoring, facilitating prompt and precise treatment decisions in acute care settings.","categories":["clinical Care","diagnostic Support","patient Facing","neurology","acute Care Management","Clinical","Diagnostic","Patient-facing","Neurology","Acute Care"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Neurologists","Intensive Care Unit (ICU) Staff","Emergency Department (ED) Staff"],"specialties":["Neurology","Critical Care","Emergency Medicine"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"Enterprise_Quote","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States"],"company_founding":"2017","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Real-time EEG diagnostics","Continuous EEG monitoring","Automatic detection of suspected status epilepticus","Diagnosis of electrographic status epilepticus","Seizure burden estimation","Medication effectiveness monitoring","Seizure burden display with pre-annotations","Instantaneous bedside alerts for status epilepticus","Cloud-based AI algorithm","24/7 continuous EEG monitoring and alerts","Seizure burden display with pre-annotations to support efficient EEG interpretation","Real-time medication effectiveness monitoring","Intuitive medication response monitoring","FDA-cleared instantaneous bedside alert diagnosing electrographic status epilepticus","Continuous EEG monitoring and seizure burden display","Easily annotate medications at the bedside with just a touch","Intuitive medication response monitoring can enable treatment optimization in real-time"],"optional_modules":["EEG Portal","ClarityPro AI algorithm"],"integrations":["Ceribell EEG system","EEG headbands","EEG Portal"],"data_standards":["EEG data","Seizure burden data","Medication data"],"api_available":"unknown","system_requirements":"Ceribell EEG system, EEG headbands","compliance":["FDA 510(k) clearance","FDA Breakthrough Device Designation","CMS New Technology Add-on Payment (NTAP)","FedRAMP High authorization","HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k) clearance","FDA Breakthrough Device Designation","CMS New Technology Add-on Payment (NTAP)","FedRAMP High authorization","FDA clearance for pediatric patients aged 1 and older"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"\"\"","integration_partners":[],"id":"SW0351","slug":"claritypro-ai","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/claritypro-ai.json"}}