SignalHF Predictive AI
The FDA-cleared AI Algorithm¹ That Predicts HF Hospitalizations.
The context
Addressing Heart Failure: A Vital Concern for Patients and Health Systems
Our solution
SignalHF Predictive AI¹
FDA-Cleared Algorithm
Advancing Care Quality for Individuals with Heart Failure
Your benefits
- Unified Device Data: Centralizes and standardizes all cardiac implantable device data into one platform.
- AI-Driven Alert Management: Filters alerts with FDA-cleared algorithms and highlights clinically relevant events for faster decisions.
- Smart Workflow Automation: Provides real-time access anywhere and automates billing workflows and reporting.
How Does It Work?
The First Manufacturer-Agnostic HF Prediction Score Based on CIED Data
– SignalHF⁴ is an FDA-cleared AI algorithm
– Uses data collected from CIEDs (PM, CRT-P, ICD, CRT-D)
– Algorithm is agnostic for Biotronik, Boston Scientific and Medtronic CIEDs using 90 days of physiological data, demographics, lead measurements and episodes & therapies
– Evaluates the risk of HF hospitalizations in the next 30 days
– Generates alerts for SignalHF score above alert threshold
Clear factors. Clear actions.
Actionable Insights
– Leverage contributing factors to quickly pinpoint relevant physiological signals
– Identify clear next steps based on SignalHF’s assessment:
- Check patient symptoms, with a phone call or an automated SMS
- Pause the alert to follow up on the patient in a few days
- Adapt medication
¹SignalHF FDA cleared Class II medical device. Manufacturer: Implicity. The SignalHF System is intended for use by qualified healthcare professionals (HCP) managing patients over 18 years old who are receiving physiological monitoring for Heart Failure surveillance and implanted with a compatible Cardiac Implantable Electronic Devices (CIED) (i.e., compatible pacemakers, ICDs, and CRTs). The SignalHF System provides additive information to use in conjunction with standard clinical evaluation.
The SignalHF HF Score is intended to calculate the risk of HF for a patient in the next 30 days. This System is intended for adjunctive use with other physiological vital signs and patient symptoms and information and is not intended to independently direct therapy. See the instructions for use for more information. SignalHF is not available for sale in Europe.
² Groenewegen, A., Rutten, F. H., Mosterd, A., & Hoes, A. W. (2020). Epidemiology of heart failure. European Journal of Heart Failure, 22(8), 1342–1356. doi:10.1002/ejhf.1858
³ Healthcare Cost and Utilization Project (HCUP). (2011). HCUP Facts and Figures: Statistics on Hospital-Based Care in the United States, 2009. Agency for Healthcare Research and Quality (US).
⁴ SignalHF is compatible with ICD/CRT-D from Medtronic, Boston Scientific and Biotronik and IPG/CRT-P from Medtronic and Biotronik able to measure thoracic impedence.
⁵ “Heart Failure Events Prediction Algorithm for Patients Implanted With Multi-brand CIED – FORESEE-HF StudyResults”. N. Varma. EHRA 2024.
⁶ Number of days before the event when the alert is reached (for 75% of the events).
