{"product_name":"Sepsis ImmunoScore","company_name":"Prenosis","product_url":"https://www.prenosis.com/sepsis-immunoscore","company_url":"https://www.prenosis.com","related_urls":["https://navify.roche.com/us/en-us/marketplace/products/algorithms/navify-algorithms-sepsis-immunoscoretm-by-prenosis","https://www.prnewswire.com/news-releases/prenosis-announces-commercial-distribution-collaboration-with-roche-for-sepsis-immunoscore-the-first-fda-de-novo-authorized-artificial-intelligence-tool-for-sepsis-detection-302112509.html","https://www.prnewswire.com/news-releases/prenosis-announces-fda-de-novo-marketing-authorization-of-the-sepsis-immunoscore-its-revolutionary-artificial-intelligence-diagnostic-and-predictive-tool-for-early-sepsis-detection-302106453.html","https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0237","summary":"Sepsis ImmunoScore is an FDA-authorized AI diagnostic tool developed by Prenosis to assist healthcare providers in early detection and prediction of sepsis risk in patients.","description":"Sepsis ImmunoScore leverages artificial intelligence to analyze up to 22 patient parameters, including lab biomarkers, vital signs, and demographics, to generate a sepsis risk score. This score aids clinicians in identifying patients at risk for sepsis or developing sepsis within 24 hours, facilitating timely intervention and potentially improving patient outcomes. The tool integrates directly into electronic health records (EHRs), providing an intuitive display of risk parameters and model calculations to support clinical decision-making. In 2024, Sepsis ImmunoScore received FDA De Novo marketing authorization, marking it as the first AI diagnostic tool for sepsis detection. Additionally, Prenosis announced a commercial distribution collaboration with Roche Diagnostics to bring Sepsis ImmunoScore to hospitals across the U.S.","categories":["clinical Decision Support","diagnostic Support","predictive Analytics","Clinical Decision Support","Diagnostic","Predictive Analytics"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Nurses","Healthcare Providers"],"specialties":["Infectious Disease","Critical Care","Emergency Medicine"],"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":"2018","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["AI-driven sepsis risk assessment","Predicts sepsis onset within 24 hours","Integrates with electronic health records (EHR)","Utilizes up to 22 patient parameters","Assigns patients to discrete risk categories","Provides intuitive visualization of risk parameters","Supports clinical decision-making","FDA De Novo authorized"],"optional_modules":[],"integrations":["navify Algorithm Suite by Roche"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 21 CFR Part 820","ISO 13485","ISO 27001"],"certifications":["FDA De Novo Authorization","ISO 13485","ISO 27001"],"security_features":["Encryption","RBAC","Audit logs","2FA"],"privacy_features":["BAA available","Consent management","Data anonymization","Data minimization"],"data_residency":"US-only","customers":["Roche","Navify","FDA","Sg2","Atria AI","Amazon Web Services (AWS)","Pulsifi","IBM","CareValidate","Qualtrics","Kirusa","Bizmatics","SolarWinds","Datadog","New Relic","IBM Instana","Progress WhatsUp Gold","Checkmk","Pandora FMS","Zabbix","cPanel","FusionReactor APM","Semalytix","Sg2 Analytics","PrognoCIS","Navify Algorithms","Care360","Safe Reopening","Pharos","Sg2 Intelligence"],"user_reviews":["Industry leading tool for voice infrastructure monitoring. They also have solutions for payment and distributed infrastructure monitoring.","The backend UI needs an upgrade. Few performance issues observed."],"ratings":["5/5 on G2 for Care360 by CareValidate","4.5/5 on G2 for Qualtrics Vaccination & Testing Manager","5/5 on G2 for Sg2 Intelligence","4.2/5 on G2 for Pulsifi","4.2/5 on G2 for Amazon Comprehend Medical","5/5 on G2 for Atria AI","4.3/5 on G2 for SolarWinds Observability","4.4/5 on G2 for Datadog","4.4/5 on G2 for New Relic","4.4/5 on G2 for IBM Instana"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2020","integration_partners":["Roche","Navify","FDA","Sg2","Atria AI","Amazon Web Services (AWS)","Pulsifi","IBM","CareValidate","Qualtrics","Kirusa","Bizmatics","SolarWinds","Datadog","New Relic","IBM Instana","Progress WhatsUp Gold","Checkmk","Pandora FMS","Zabbix"],"id":"SW0237","slug":"sepsis-immunoscore","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/sepsis-immunoscore.json"}}