{"product_name":"EpiMonitor","company_name":"Empatica","product_url":"https://www.empatica.com/epimonitor","company_url":"https://www.empatica.com","related_urls":["https://apps.apple.com/us/app/epimonitor-by-empatica/id1669234452","https://www.businesswire.com/news/home/20240227351574/en/Empatica-Reveals-Next-Generation-FDA-Cleared-Epilepsy-Watch-and-Launches-AI-Seizure-Forecasting-Study","https://www.afp.com/index.php/en/infos/empatica-achieves-ce-mdr-certification-epimonitor-bringing-round-clock-epilepsy-monitoring","https://www.epilepsyalarms.co.uk/product/epimonitor/","https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0254","summary":"EpiMonitor by Empatica is an FDA-cleared wearable device designed to detect generalized tonic-clonic seizures and provide continuous health monitoring for individuals with epilepsy.","description":"EpiMonitor is a medical-grade wearable solution that combines the EmbracePlus smartwatch with a companion smartphone app to monitor health data, detect potential seizures, and alert caregivers promptly. It offers features such as automated seizure detection with 98% accuracy, up to 7 days of battery life, sleep and activity tracking, and a seizure diary for comprehensive health management.","categories":["clinical Care","patient Facing","diagnostic Support","remote Monitoring","Clinical","Patient-facing","Diagnostic","Monitoring"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Patients","Caregivers","Clinicians"],"specialties":["Neurology","Epilepsy Care"],"regions_available":["United States","Germany","France","Italy","Spain","Denmark","Sweden","Belgium","Luxembourg","Austria","Liechtenstein","Ireland","Netherlands","Malta","Finland"],"languages_supported":["English","Spanish","French","Italian","German","Dutch","Danish","Swedish"],"pricing_model":"Subscription","pricing_details":"One-time device fee of $399; monthly subscriptions starting at $15.90; 30-day money-back guarantee; 1-year warranty.","license":"Commercial","company_offices":["United States","Italy","Germany","France","United Kingdom","Denmark","Sweden","Belgium","Luxembourg","Austria","Liechtenstein","Ireland","Netherlands","Malta","Finland"],"company_founding":"2014","deployment_model":["SaaS"],"os_platforms":["iOS","Android"],"features":["FDA-cleared seizure detection with 98% accuracy","Automated alerts to caregivers via call and SMS","Self-triggered alerts for user-initiated assistance","Seizure, sleep, and activity diaries","Sleep and activity tracking with detailed reports","Up to 7 days of battery life","Adjustable sensing precision to reduce false alerts","User-friendly mobile app available in 8 languages"],"optional_modules":["Seizure forecasting study participation"],"integrations":["Empatica Cloud API","Clinical trial management software"],"data_standards":["HL7","FHIR","DICOM"],"api_available":"yes","system_requirements":"Bluetooth 5.0 or higher, iOS 16 or higher, Android 12 or higher","compliance":["FDA 510(k)","CE MDR","ISO 13485:2021","ISO/IEC 27001:2013","HIPAA","GDPR"],"certifications":["FDA 510(k)","CE MDR","ISO 13485:2021","ISO/IEC 27001:2013"],"security_features":["Encryption","RBAC","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US and EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0254","slug":"epimonitor","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/epimonitor.json"}}