{"product_name":"eCARTv5 Clinical Deterioration Suite","company_name":"AgileMD","product_url":"https://www.agilemd.com/ecartv5","company_url":"https://www.agilemd.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0202","summary":"eCARTv5 Clinical Deterioration Suite is an AI-driven software that continuously assesses hospitalized patients' risk of deterioration, aiding clinicians in early intervention decisions.","description":"eCARTv5 Clinical Deterioration Suite is an AI-powered software as a medical device (SaMD) developed by AgileMD. It utilizes machine learning algorithms to continuously evaluate hospitalized patients' risk of impending death or intensive care unit (ICU) transfer. Integrated directly into electronic health records (EHR), eCARTv5 analyzes up to 97 real-time variables, including laboratory results, vital signs, and nursing assessments, to generate an eCART score and risk designation. This assists medical staff in promptly and accurately identifying patients requiring increased medical attention. The software has been validated through extensive clinical performance data from nearly two million hospitalizations across 21 hospitals, ensuring consistent accuracy across diverse patient demographics and medical conditions. eCARTv5 is the result of over a decade of research at the University of Chicago and has received FDA 510(k) marketing clearance for its clinical use. ([businesswire.com](https://www.businesswire.com/news/home/20240625599976/en/AgileMD-receives-FDA-clearance-for-eCART-to-predict-in-hospital-clinical-deterioration-across-medical-conditions?utm_source=openai))","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["enterprise"],"target_users":["clinicians","nurses","admins"],"specialties":["General Medicine","Cardiology","Pulmonology","Infectious Diseases","Neurology","Gastroenterology","Orthopedics","Oncology","Hematology","Nephrology","Endocrinology","Rheumatology","Dermatology","Psychiatry","Obstetrics And Gynecology","Pediatrics","Geriatrics","Urology","Emergency Medicine","Anesthesiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States"],"company_founding":"2014","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["AI-driven clinical deterioration prediction","Continuous assessment of patient risk","Embedded into electronic health records (EHR)","Utilizes up to 97 real-time variables","Provides eCART score and risk designation","Guides clinical staff to embedded clinical pathways","Supports all-cause clinical deterioration prediction","Minimizes false alarms","Reduces clinician workload","Ensures consistent accuracy across diverse patient demographics","FDA 510(k) marketing clearance"],"optional_modules":[],"integrations":["Electronic Health Records (EHR) systems"],"data_standards":["FHIR","HL7 v2","DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance"],"security_features":["Embedded into EHR","Utilizes real-time variables","Guides clinical staff to clinical pathways"],"privacy_features":["Embedded into EHR","Utilizes real-time variables","Guides clinical staff to clinical pathways"],"data_residency":"US","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0202","slug":"ecartv5-clinical-deterioration-suite","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/ecartv5-clinical-deterioration-suite.json"}}