SignalHF · FDA-cleared · Class II

SignalHF^‡: an early read on heart failure risk, from the devices your patients already have.

SignalHF^‡ reads 90 days of CIED data together and estimates the risk of a heart failure hospitalization in the next 30 days. In an analysis of ICD and CRT-D patients presented at EHRA 2024, SignalHF showed 60% sensitivity for heart failure hospitalization, with alerts raised an average of 35 days before the event.¹

Heart failure in the U.S.

Heart failure is common. The warning signs are quiet.

Heart failure is the leading cause of hospitalization for U.S. adults over 65.² For patients with a pacemaker, ICD or CRT device, many of the physiological signals clinicians watch are already being recorded between visits.

Prevalence

6.7M

U.S. adults are living with heart failure today, a number projected to reach 8.7 million by 2030.²

Lifetime risk

24%

lifetime risk of developing heart failure, roughly 1 in 4 people.²

Mortality

425K+

U.S. deaths a year are linked to heart failure.³

Your patients’ devices are already recording the signals. SignalHF^‡ reads them together.

How it works

Many quiet signals, one score you can act on.

No single reading tells the whole story. SignalHF^‡ combines physiological trends, lead measurements, episodes and therapies, and demographics into one 30-day risk score.

01
Your CIEDs transmitPacemakers, ICDs and CRT devices send thoracic impedance, heart rate, activity, rhythm and more.
02
SignalHF^‡ reads 90 days togetherThe algorithm weighs each trend against the others, across manufacturers, and updates the patient’s risk score.
03
An alert when risk crosses the thresholdThe alert arrives with the factors that drove the score, so you can see why the patient was flagged.
04
Your team decides the next stepCheck symptoms by phone or SMS, follow up in a few days, or adapt treatment. The decision stays yours.

Illustrative animation of the scoring flow; values and threshold are not study data.

Inside the workflow

Not just a number. The reasons behind it.

Every SignalHF^‡ score shows the factors that contributed to it, so your team can quickly see what changed and decide what to do next. Try a few examples.

ICD · MedtronicLast 90 days

90 days agoToday

HF risk score0Scoring…

Top contributing factors

Thoracic impedance+24
Night heart rate+15
Activity+12
Atrial arrhythmia+9

Illustrative examples. Not actual patient data or algorithm output; every alert is reviewed by your clinical team.

Clinical evidence

On average35 days

of advance alert before a heart failure hospitalization, with 60% sensitivity, in a multi-brand CIED analysis.¹

EP Europace · 2024Heart failure events prediction algorithm for patients implanted with multi-brand CIEDsPresented at EHRA 2024 by Varma, Boveda, Singh and colleagues. Results in ICD and CRT-D patients:¹

60%sensitivity for HF hospitalization

35 daysaverage alert ahead of the event

0.66unexplained alerts per patient-year

FDA 510(k) · Class IICleared as a Class II medical device^‡For qualified healthcare professionals managing adult HF patients with a compatible CIED, as an adjunct to standard clinical evaluation.

Manufacturer-agnosticA heart failure risk score built on multi-brand CIED dataOne model across compatible Medtronic, Boston Scientific and Biotronik devices, inside the same platform you use for remote monitoring.^‡

Compatibility

Three manufacturers.
One HF risk score.

Most clinics follow devices from more than one manufacturer, each with its own HF diagnostics and its own portal. SignalHF^‡ applies one consistent score across compatible devices that can measure thoracic impedance.

ICD · CRT-D · IPG · CRT-P

ICD · CRT-D

ICD · CRT-D · IPG · CRT-P

Compatible devices must be able to measure thoracic impedance. See the instructions for use for the full list.^‡

Decompensation rarely announces itself all at once. It builds quietly across impedance, heart rate, activity and rhythm. SignalHF^‡ reads those signals together, so your team can start the conversation sooner.

FAQ

Questions clinics ask us most.

What is SignalHF^‡?

An FDA-cleared Class II software medical device^‡ that analyzes 90 days of data from compatible cardiac implantable electronic devices (CIEDs). It estimates a patient’s risk of heart failure hospitalization in the next 30 days and alerts the care team when the score crosses the alert threshold.

Does SignalHF^‡ direct therapy?

No. SignalHF^‡ is intended for adjunctive use alongside other vital signs, symptoms and patient information. It gives a qualified healthcare professional additional information and is not intended to independently direct therapy.

Which devices is it compatible with?

ICD and CRT-D devices from Medtronic, Boston Scientific and Biotronik, and IPG and CRT-P devices from Medtronic and Biotronik that are able to measure thoracic impedance. It is intended for patients over 18 receiving physiological monitoring for heart failure surveillance.^‡

What data does the score use?

Ninety days of physiological data, lead measurements, and episodes and therapies from the device, together with patient demographics. Examples of contributing factors include thoracic impedance, heart rate, activity, atrial and ventricular arrhythmias, respiratory rate and pacing.^‡

What happens when SignalHF^‡ raises an alert?

The alert appears in the Implicity platform with the factors that contributed to the score. Your team decides the next step, for example checking symptoms by phone or automated SMS, pausing the alert to follow up in a few days, or adapting treatment.

How do we get started?

Request a demo and we’ll walk you through the setup for your program.

Read the signals · Act sooner ·

See it coming ·

See which of your HF patients SignalHF^‡ would put in front of your team first.

Explore the platform

‡SignalHF is an FDA-cleared Class II medical device (Manufacturer: Implicity), intended for qualified healthcare professionals managing patients over 18 years old who are receiving physiological monitoring for heart failure surveillance and have a compatible CIED. The SignalHF HF Score estimates the patient’s risk of heart failure hospitalization in the next 30 days. It provides additional information to be used in conjunction with standard clinical evaluation, is intended for adjunctive use with other vital signs, symptoms and patient information, and is not intended to independently direct therapy. 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 impedance. See the instructions for use for more information.
†IM007 ILR ECG Analyzer is an FDA cleared Class II medical device, see the instructions for use for more information.
1Varma N, Boveda S, Ibnouhsein I, Faedda G, Rosier A, Singh J. Heart failure events prediction algorithm for patients implanted with multi-brand CIED. Europace. 2024;26(Suppl 1):euae102.553. doi:10.1093/europace/euae102.553. Conference abstract; performance shown for ICD/CRT-D patients.
2Fonarow GC, Ahmad FS, Ahmad T, et al. HF STATS 2025: Heart Failure Epidemiology and Outcomes Statistics. A report of the Heart Failure Society of America. J Card Fail. 2025. doi:10.1016/j.cardfail.2025.07.007
3Palaniappan LP, Allen NB, Almarzooq ZI, et al. 2026 Heart Disease and Stroke Statistics: a report of US and global data from the American Heart Association. Circulation. 2026;153(9):e275-e906. doi:10.1161/CIR.0000000000001412

The Implicity platform is a clinical decision support device and is in no way intended to replace the responsibility or clinical judgment of the practitioner. It is designed to optimize data workflows and support medical expertise in patient management.