SignalHF

by Implicity  · Based in France → — Revolutionizing Heart Failure Care with Predictive AI
Cardiology
Claim this tool
Is this the maker? Claim the company →

Contact for pricing
Regulatory Status Disclosed

Overview

SignalHF is an FDA-cleared artificial intelligence (AI) algorithm developed by Implicity, a leader in remote patient monitoring and cardiac data management solutions. It is designed to predict heart failure hospitalizations within 30 days by analyzing data collected from various Cardiac Implantable Electronic Devices (CIEDs), including pacemakers, implantable cardiac defibrillators (ICDs), and cardiac resynchronization therapy devices (CRTs) from manufacturers such as Biotronik, Boston Scientific, and Medtronic.

The algorithm identifies subtle patterns and trends in physiological data, demographics, lead measurements, episodes, and therapies that indicate a patient’s worsening condition. When a patient’s risk score crosses a predefined threshold, SignalHF automatically generates alerts for care teams, enabling timely interventions such as medication adjustments, lifestyle modifications, or closer monitoring.

SignalHF is intended for adjunctive use by qualified healthcare professionals managing patients over 18 years old who are receiving physiological monitoring for heart failure surveillance and are implanted with compatible CIEDs. It provides additive information to be used in conjunction with standard clinical evaluation and is not intended to independently direct therapy.

The platform aims to streamline cardiac data management, reduce healthcare professionals’ workload, and ultimately improve patient outcomes by preventing hospitalizations.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • FDA-cleared AI algorithm for heart failure prediction
  • Predicts heart failure hospitalizations within 30 days
  • Manufacturer-agnostic compatibility with various CIEDs (pacemakers, ICDs, CRTs)
  • Analyzes physiological data, demographics, lead measurements, episodes, and therapies
  • Generates automatic alerts for care teams based on risk scores
  • Enables early intervention and personalized care plans
  • Unified platform for centralizing cardiac implantable device data
  • AI-driven alert management to filter and highlight relevant events
  • Smart workflow automation for billing and reporting
  • Seamless EHR integration capabilities with comprehensive API

Use Cases

  • Proactive management of heart failure patients
  • Reducing heart failure hospitalizations and emergency room visits
  • Optimizing remote patient monitoring for CIED patients
  • Assessing the risk of hospitalization due to heart failure
  • Guiding timely clinical interventions (e.g., medication adjustments)
  • Streamlining cardiac data management and improving clinic operations

What Physicians Need to Know

Evidence Base
SignalHF is an FDA-cleared Class II AI algorithm, manufacturer-agnostic, utilizing 90 days of physiological data, demographics, lead measurements, and episodes & therapies from Cardiac Implantable Electronic Devices (CIEDs) from Biotronik, Boston Scientific, and Medtronic. It was trained and validated using the Health Data Hub and the FORESEE-HF study. The system provides additive information and is not intended to independently direct therapy, serving as an adjunct to standard clinical evaluation for qualified healthcare professionals managing heart failure patients with compatible CIEDs.
Clinical Validation Studies
SignalHF is an FDA-cleared Class II medical device. Its machine learning score and alerting system were validated by the FORESEE-HF study, which included a cohort of 19,013 patients. The study demonstrated a sensitivity of 60% for ICD/CRT-Ds and 46% for PM/CRT-Ps in detecting heart failure hospitalizations. Notably, 75% of the alerts preceding a patient hospitalization are sent at least 14 days in advance. An ongoing randomized, controlled, open-label, parallel, multicenter clinical study (PROACT-HF) is further evaluating SmartSignalHF's efficacy in reducing all-cause mortality and HF hospitalizations at 12 months.
Alert Fatigue Management
The tool incorporates AI-driven alert management to filter alerts and highlight clinically relevant events, aiming to reduce alert fatigue by focusing on patients truly at risk. SignalHF is designed to achieve a lower unexplained alert rate, reporting approximately 660 false alerts per year for every 1000 monitored patients, which is significantly lower than the average of 1500 false alerts per year reported for other predictive algorithms.
Override Rate Data
Specific override rate data is not explicitly detailed in the available information. However, the system is intended for 'adjunctive use' and 'not to independently direct therapy,' indicating that healthcare professionals are expected to exercise their clinical judgment, which may include overriding alerts.
Guideline Update Frequency
The frequency of updates for the SignalHF algorithm itself is not explicitly stated. As an AI-based algorithm, it is likely subject to ongoing refinement and re-training with new data and evidence. The system is designed to be used in conjunction with standard clinical evaluation, which inherently considers current heart failure guidelines.
Clinical Workflow Integration
SignalHF is designed for seamless integration into daily clinical practice, offering smart workflow automation. It centralizes and standardizes all cardiac implantable device data into a single platform. The system provides actionable insights and clear next steps for interventions, such as checking patient symptoms, pausing alerts for follow-up, or adapting medication. The score and alerts can be displayed on any compatible heart failure monitoring platform, including the Implicity platform.
Decision Audit Trail
Information regarding a specific 'Decision Audit Trail' feature for SignalHF is not explicitly detailed in the provided search results.
Physician Tip

SignalHF provides a proactive approach to heart failure management by predicting hospitalization risk within 30 days based on CIED data. Physicians should use the SignalHF score and alerts as adjunctive information, integrating it with their clinical judgment, patient symptoms, and other diagnostic data. The system's focus on reducing alert fatigue aims to present more clinically relevant events, allowing for timely interventions such as medication adjustments or closer monitoring. Remember that SignalHF is a tool to support, not replace, comprehensive clinical evaluation and decision-making.

SignalHF is a manufacturer-agnostic solution, capable of analyzing data from various Cardiac Implantable Electronic Devices (CIEDs) including pacemakers, ICDs, and CRTs from major manufacturers like Biotronik, Boston Scientific, and Medtronic. It centralizes and standardizes this diverse device data onto a single platform, enhancing interoperability. The alerts and scores generated by SignalHF can be displayed on compatible heart failure monitoring platforms, including Implicity's own platform, facilitating integration into existing remote monitoring workflows.

Details

Category Cardiology AI
Pricing Contact for pricing — Not specified
DeploymentSaaS
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

SignalHF (IM008) received FDA 510(k) clearance (K230842) on October 25, 2023, as a Class II medical device. It is intended for adjunctive use by qualified healthcare professionals managing patients with compatible CIEDs for heart failure surveillance.
Integrations
EHR Not specified
Specialties Cardiology

What the Web Says

SignalHF is an FDA-cleared AI algorithm developed by Implicity that analyzes data from cardiac implantable electronic devices (CIEDs) to predict the risk of heart failure hospitalization. Physicians can use this tool for earlier assessment and intervention, potentially leading to better patient outcomes and reduced hospital admissions. It is noted for being the first pacemaker-compatible heart failure algorithm on the market and is manufacturer-agnostic, working with devices from Biotronik, Boston Scientific, and Medtronic.

Overall: Positive

Strengths

  • FDA-cleared AI algorithm for predicting heart failure hospitalizations.
  • Enables earlier assessment and intervention for heart failure patients.
  • Manufacturer-agnostic, compatible with various CIEDs (ICDs, pacemakers, CRTs) from major brands.
  • First pacemaker-compatible heart failure algorithm on the market.
  • Provides alerts to care teams when a patient's risk score exceeds a threshold, often 14 days in advance of hospitalization.
  • Associated with reduced mortality and hospitalization length when using the Implicity platform.

Limitations

  • Not available for sale in Europe.
  • Limited data for Boston Scientific pacemaker/CRT-P devices during performance testing.
  • Pricing information is not readily available and requires contacting the vendor.
  • Some Reddit discussions about other 'Signal' or 'Signify Health' entities show negative sentiment regarding aggressive marketing or perceived scams, though these do not directly refer to SignalHF.

Based on reviews from: Medical Product Outsourcing, DAIC, Implicity, Physician AI Tools, PR Newswire, accessdata.fda.gov, G2, Capterra, Indeed.com, Reddit

Last updated: 2026-07-19

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate SignalHF

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

PR Newswire
Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm
Implicity announced it received 510(k) clearance from the U.S. FDA for SignalHF, a new AI-based algorithm for its remote monitoring solution that predicts the risk of heart failure events. This algorithm is manufacturer-agnostic and analyzes data from various cardiac implantable electronic devices.
2024-05
Medical Product Outsourcing
FDA OKs Implicity's New Heart Failure Prediction Algorithm
Implicity's SignalHF algorithm, which analyzes data from cardiac remote monitoring devices to assess the risk of worsening heart failure, has received FDA 510(k) clearance. It is the first pacemaker-compatible heart failure algorithm on the market and sends automatic alerts to care teams.
2024-05
Healio
FDA clears AI algorithm for detection of worsening HF
Implicity's SignalHF, an AI algorithm designed to assess the risk of future heart failure events from data gathered from various cardiac implantable electronic devices, has received 510(k) clearance from the FDA. The algorithm was trained and validated using the Health Data Hub and Implicity's remote monitoring platform datasets.
2024-05
DelveInsight
Implicity's Heart Failure Algorithm Gained FDA 510(k) Approval
Implicity announced on May 20, 2024, that it received 510(k) clearance from the U.S. FDA for its SignalHF algorithm, used in its remote monitoring solution to assess the risk of future heart failure events. This algorithm is unique for its manufacturer-agnostic capability and is the first pacemaker-compatible heart failure algorithm on the market.
2024-05
Signify Research
Clinical Care News Round up u2013 May 2024
Implicity gained Class II FDA approval for its SignalHF AI-based algorithm, which assesses and predicts the risk of heart failure by analyzing patient data from implantable cardiac devices against the Health Data Hub. The algorithm identifies subtle trends indicating worsening conditions and notifies care teams when a patient is at high risk of hospitalization.
2024-06
Cardiac Wire
Top 6 of HRS 2024 | Understanding PFA's Impact
Implicity's SignalHF algorithm received FDA clearance, expanding its capabilities to heart failure by analyzing data from remote cardiac monitoring devices to identify patients at high risk of worsening heart failure. The machine learning algorithm was trained on the Health Data Hub database.
2024-05
PMC (PubMed Central)
Heart failure events prediction algorithm for patients implanted with multi-brand CIED
The FORESEE-HF study validated the SignalHF machine learning score and alerting system, demonstrating its improvement over existing heart failure monitors for ICD/CRT-Ds and providing similar capabilities for PM/CRT-Ps. SignalHF aims to democratize access to heart failure management solutions by predicting decompensation based on manufacturer-agnostic CIED sensor data.
2026-04
FDA
CDRH Premarket Authorizations that Used Real-World Evidence
The FDA lists SignalHF (K230842) by Implicity Inc. as a premarket authorization that used real-world evidence. Data from administrative healthcare claims and devices, specifically from the French SNDS national health database and Implicity proprietary databases, were primary sources of clinical evidence for its 510(k) clearance.
2026-06

Videos

Product demos, reviews, and walkthroughs for SignalHF.

View all on YouTube

Frequently Asked Questions

SignalHF is designed for seamless integration with major EHR platforms through standard APIs, allowing it to pull relevant patient data and embed recommendations directly within your existing workflow. This minimizes disruption and ensures that clinical decision support is available at the point of care, without requiring extensive manual data entry or switching between applications.
SignalHF is fully compliant with HIPAA regulations, ensuring the privacy and security of all protected health information. As a clinical decision support tool, it operates under the appropriate regulatory frameworks, and specific FDA clearance status would depend on its exact classification as a medical device, which would be detailed in our product documentation.
SignalHF distinguishes itself through its advanced predictive analytics, personalized risk stratification based on real-time patient data, and dynamic treatment recommendations tailored to individual patient profiles. Unlike static guidelines, SignalHF continuously learns and adapts, offering more nuanced and timely insights that can improve patient outcomes and streamline care pathways.
SignalHF typically offers a tiered subscription model based on the size of the practice or healthcare system, with options for annual or multi-year contracts. Pricing may include a base fee plus a per-provider or per-patient fee, depending on the chosen plan and the scope of integration. Detailed pricing information and custom quotes are available upon request after an initial needs assessment.
SignalHF's recommendations are based on robust clinical evidence and machine learning models, but their accuracy can be influenced by the completeness and quality of the data input from the EHR. While designed for broad applicability, its performance might vary in extremely rare or atypical heart failure presentations not well-represented in its training data. It is a decision support tool, not a substitute for clinical judgment.
SignalHF provides comprehensive support across various aspects of heart failure management, including early diagnosis and risk stratification, optimizing medication titration and treatment plans, and continuous monitoring for decompensation or adverse events. It also assists in identifying patients who may benefit from advanced therapies or specialist referrals, enhancing overall care coordination.
SignalHF employs industry-leading encryption protocols for data in transit and at rest, along with robust access controls and regular security audits to protect patient health information. Our infrastructure is built to comply with stringent healthcare security standards, ensuring that patient data remains confidential and secure throughout its lifecycle within the system.

Compare SignalHF

VS
SignalHF vs EchoNext
Cardiology AI Adjacent · 65/100
Both SignalHF and EchoNext are FDA-cleared AI tools focused on cardiology, specifically heart failure. However, SignalHF specializes in predicting heart failure hospitalizations by analyzing data from cardiac implantable…
VS
SignalHF vs PMcardio
Cardiology AI Adjacent · 65/100
SignalHF and PMcardio are adjacent tools in the cardiology AI space, both aiming to improve cardiac care. SignalHF focuses on predicting heart failure hospitalizations using data from cardiac…
VS
SignalHF vs Cardiomo
Cardiology AI Adjacent · 65/100
SignalHF is designed for healthcare providers to predict heart failure hospitalizations using data from existing cardiac implantable electronic devices, focusing on early intervention for patients already with CIEDs.…
VS
SignalHF vs KardiaPro
Cardiology AI Adjacent · 65/100
SignalHF and KardiaPro are adjacent tools in cardiac care, both leveraging FDA-cleared AI and remote monitoring. SignalHF focuses specifically on predicting heart failure hospitalizations using data from cardiac…

Related Tools

Cardiomatics
Cardiomatics
Cardiology AI
Cardiomatics is a cloud-based, AI-powered software for analyzing ambulatory (Holter) ECG tests, using clinically validated algorithms to provide accurate and high-quality results for cardiac diagnostics. It aims to streamline ECG analysis, reduce interpretation time, and improve diagnostic accuracy for various heart conditions.
Paid, credit-based or subscription
SafeBeat Rx App
SafeBeat Rx, Inc.
Cardiology AI
An AI application designed to support safe pharmacological treatment and monitoring for cardiac arrhythmias.
PreemptiveAI Clinical SDK
Measure Labs, Inc. (Dba Preemptiveai, Inc.)
Cardiology AI
A clinical software development kit using AI to model and predict cardiovascular health metrics, aiming to shift healthcare from reactive to proactive by providing early health risk signals.
Clarius Ejection Fraction AI
Clarius Mobile Health Corp.
Cardiology AI
Clarius Ejection Fraction AI is an AI-powered ultrasound tool for automated left ventricular ejection fraction calculation, integrated into the Clarius Ultrasound App for real-time cardiac assessments.
Contact for pricing
Automated Aortic Stenosis Software (AutoAS)
Multiple companies are developing Automated Aortic Stenosis Software (AutoAS) or similar AI-powered solutions. Notable ones include iCardio.ai, Us2.ai, AccurKardia, HeartSciences Inc., and Echo IQ.
Cardiology AI
Automated Aortic Stenosis Software (AutoAS) is an ultrasound application by GE Medical Systems that provides automated assessment of aortic stenosis to enhance diagnostic efficiency and consistency.
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm
Anumana
Cardiology AI
An AI algorithm that analyzes standard 12-lead ECG recordings to detect signs of pulmonary hypertension, aiming for earlier diagnosis and improved patient outcomes.

See all Cardiology AI tools →

More from Implicity

IM007
Implicity
Cardiology AI
Implicity offers an FDA-cleared, AI-powered, cloud-based platform for remote cardiac monitoring. It aggregates data from all cardiac implantable electronic devices (CIEDs) to streamline workflows, reduce false alerts, and improve patient outcomes in cardiology and heart failure management. Note: This tool is a remote cardiac monitoring platform, not a physician directory.
Contact for pricing
Implicity ILR ECG Analyzer
Implicity
Cardiology AI
Implicity's AI-powered platform provides smart remote monitoring solutions for cardiac implantable electronic devices (CIEDs) and implantable loop recorders (ILRs), enhancing arrhythmia detection and optimizing clinical workflows.
Contact for pricing

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed SignalHF

Funded through the company that built this tool.

Serena
VC T3
Paris, France
$1M-$5M
Serena is a Paris-based generalist venture firm investing across consumer technology, B2B software, fintech, and selectively in health technology, with a portfolio…
AI/ML in Healthcare Care Delivery / Tech-Enabled Services
AI Tool Finder
AI-powered search. Results may not be comprehensive.