{"product_name":"SignalHF","company_name":"Implicity","product_url":"https://implicity.com/signal-hf-predictive-ai/","company_url":"https://implicity.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0299","summary":"SignalHF is an FDA-cleared AI algorithm developed by Implicity to predict heart failure hospitalizations by analyzing data from cardiac implantable electronic devices (CIEDs).","description":"SignalHF is an FDA-cleared AI algorithm that analyzes data from CIEDs, including pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices, to assess the risk of heart failure hospitalizations within the next 30 days. It is compatible with devices from manufacturers such as Biotronik, Boston Scientific, and Medtronic. The algorithm evaluates 90 days of physiological data, demographics, lead measurements, and episodes & therapies to generate alerts when a patient's risk score exceeds a predefined threshold, enabling timely interventions to prevent hospitalizations. Additionally, 75% of alerts preceding a patient hospitalization are sent at least 14 days in advance, offering a two-week window to adjust medications or take proactive measures. ([implicity.com](https://implicity.com/signal-hf-predictive-ai/?utm_source=openai))","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","patients"],"specialties":["Cardiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States","France"],"company_founding":"2016","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["FDA-cleared AI algorithm for heart failure hospitalization prediction","Manufacturer-agnostic compatibility with CIEDs from Biotronik, Boston Scientific, and Medtronic","Utilizes 90 days of physiological data, demographics, lead measurements, and episodes & therapies","Evaluates risk of HF hospitalizations in the next 30 days","Generates alerts for SignalHF score above alert threshold","Provides actionable insights for patient care adjustments"],"optional_modules":[],"integrations":["CIEDs from Biotronik","CIEDs from Boston Scientific","CIEDs from Medtronic"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k)"],"certifications":["FDA 510(k)"],"security_features":["Encryption","RBAC","Audit logs","2FA"],"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":"SW0299","slug":"signalhf","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/signalhf.json"}}