Background and urgency
Heart failure is a major and growing burden on healthcare systems. In the Netherlands alone, around 250,000 people live with heart failure, and each year ~38,000 new patients are diagnosed. A large proportion of these patients require hospital admission, and the risk of readmission is particularly high in the first weeks after discharge. Despite structured outpatient follow-ups, deterioration often occurs between scheduled visits, when symptoms are not yet obvious but physiological changes are already developing.
The opportunity
Remote cardiac monitoring is an international multi-billion market. Evidence from earlier home-monitoring initiatives and clinical studies referenced in the original project plan suggests that effective remote monitoring and earlier intervention can reduce hospital admissions in heart failure patients by around 44%. However, current solutions are often either too invasive, too limited (measuring only one or two parameters), too fragmented, or unable to translate multi-sensor data into reliable clinical signals without substantial manual review.
Hospitals and care providers need a complete, easy-to-deploy solution that works in the home environment without increasing clinician workload.
For more information about PCardio see: Pcardiowearables.com
Request a QuoteThe HeartGuard solution
HeartGuard is being developed as an integrated home-monitoring system for heart failure patients. The system combines a comfortable, chest-worn single wearable platform with AI-driven interpretation to generate early warning signals and actionable alerts for clinical teams.
In its current architecture, all sensing is performed on the chest using a single wearable chest strap / chest-worn device. This simplifies patient use, improves adherence, and eliminates the need for multiple wearables.
What HeartGuard measures (single chest-worn system)
Developed in close collaboration with cardiologists, HeartGuard monitors the vital functions required for clinically meaningful home monitoring of heart failure:
- Cardiac electrical activity: multi-lead ECG (e.g., 2-lead with derived leads), rhythm abnormalities, HR/HRV
- Hemodynamic function: impedance cardiography (ICG) for stroke volume, cardiac output trends, pre-ejection period, and thoracic impedance dynamics
- Respiratory function: breathing rate and breathing pattern
- Heart and lung sounds: chest-based auscultation sensors
- Body temperature
- Activity and posture: physical activity/inactivity classification
Why ICG?
ICG provides continuous, non-invasive insight into cardiac performance and hemodynamic trends, enabling earlier detection of decompensation and therapy response compared to single-parameter monitoring.
Key innovation
HeartGuard’s innovation lies in the fusion of electrical (ECG), hemodynamic (ICG), acoustic (heart/lung sounds), respiratory, temperature, and activity data within a single chest-worn platform, combined with AI-driven multi-parameter interpretation.
This enables detection of subtle deterioration patterns that would be missed by single-sensor systems. For example, changes in stroke volume or pre-ejection period (ICG) combined with altered lung sounds and respiratory patterns can indicate early decompensation before overt symptoms appear.
Consortium and capabilities
HeartGuard is developed by:
- 2M Engineering — wearable hardware platform: sensors, chest-worn form factor, electronics, recorder architecture, certification, and industrialization.
- Appbakkers — secure data platform and AI/ML: data ingestion, processing, visualization, interpretation, alerting, and clinician workflows.
The project builds on prior validated wearable platforms and is shaped through continuous feedback from cardiologists to ensure clinical relevance and adoption.
Technical development outcomes
Single chest-worn multi-sensor platform
- High-quality ECG acquisition
- Robust ICG measurement optimized for ambulatory use
- Integrated auscultation sensing for heart and lung sounds
- Sensor co-location and shielding to prevent interference and preserve signal integrity
- Comfortable, user-friendly design supporting consistent placement
Recorder and data pipeline
- Low-power continuous acquisition suitable for long-term home use
- Reliable wireless transmission and secure cloud storage
- Scalable time-series data handling for high-fidelity physiological streams
- Role-based access for clinicians and patients
AI/ML interpretation and alerting
- Automatic extraction of clinically relevant features from ECG, ICG, acoustics, and respiration
- Transparent access to raw signals to build trust
- Progressive model improvement via labeled clinical outcomes
Expected impact
Clinical and operational impact
HeartGuard enables earlier detection of hemodynamic deterioration in heart failure patients and supports safer recovery at home. By identifying changes in cardiac output dynamics and respiratory/cardiac signals before acute decompensation, HeartGuard aims to reduce preventable complications and hospital (re)admissions, easing pressure on cardiology clinics and hospital capacity.
Patient impact
Patients benefit from continuous, non-invasive monitoring in their home environment with a single, easy-to-wear chest device, improving adherence and quality of life while providing reassurance and timely intervention when needed.
Economic impact
Reduced admissions and readmissions translate into substantial healthcare cost savings. HeartGuard’s scalable model (wearable hardware + software/service licensing) supports broad deployment while enabling sustainable, data-driven heart failure care.
Proven Technical Achievements
HeartGuard is built on a mature, research-grade multisensory platform that has already been developed, tested, and validated across multiple signal modalities. Key technical milestones include:
✔ Fully Integrated Chest-Worn Multisensor Platform
We have developed a single wearable chest strap integrating:
- 2-lead ECG (with derived multi-lead reconstruction)
- Impedance Cardiography (ICG) for hemodynamic monitoring (SV, CO, PEP, LVET, TFC)
- Heart and lung sounds via integrated MEMS microphone (auscultation)
- Photoplethysmography (PPG) for SpO₂, HR and Pulse Arrival Time (PAT)
- Respiration rate derived from ECG, strain sensor and BioZ signals
- Temperature sensing (skin temperature; core temperature integration available)
- Activity and posture via IMU
All sensors are synchronized and sampled through a single wearable recorder platform.
✔ Clinical-Grade Signal Processing Pipeline
We implemented a full signal enhancement and quality assessment pipeline for physiological data, including:
- Detrending and filtering to remove baseline wander and motion artifacts
- Automated signal quality assessment using template-matching and morphology checks
- Feature extraction validated on public clinical datasets:
- ECG algorithms tested on MIT-BIH Arrhythmia Database
- ICG algorithms validated on ReBeatICG dataset
- Respiration rate benchmarked against Oxycon reference systems
Performance values are comparable to reported literature, demonstrating clinical relevance of extracted parameters.
✔ Multi-Modal Parameter Extraction
HeartGuard already supports extraction of clinically meaningful parameters across modalities:
ECG
- R, Q, S, T, P point detection
- HR, HRV, ST-segment changes
- Detection of bradycardia, tachycardia, ischemia indicators
ICG
- Stroke Volume (SV)
- Cardiac Output (CO)
- Pre-Ejection Period (PEP)
- Left Ventricular Ejection Time (LVET)
- Thoracic Fluid Conductivity (TFC)
- Hemodynamic trends linked to heart failure decompensation
PPG
- SpO₂
- HR, HRV
- Pulse Arrival Time (PAT)
Respiration
- Reliable respiration rate derived from ECG, strain sensor and impedance signals
This enables true multi-parameter trend analysis instead of isolated single-sensor metrics.
✔ Firmware & Embedded Systems Engineering
The HeartGuard platform is built on a robust embedded architecture:
- Load-balanced synchronized sampling across multiple external sensors
- Buffered acquisition with clock drift compensation to maintain temporal alignment
- BLE and USB connectivity
- Expandable onboard memory (8GB)
- Integrated microphone acquisition (PDM MEMS)
- Modular sensor firmware enabling rapid integration of new “software sensors”
This architecture allows high-fidelity physiological data capture without bottlenecks or data loss.
✔ Wearable Design Validated for Real-World Use
The wearable chest strap and electrode system have been tested on multiple users:
- Textile dry electrodes selected after sweat corrosion and long-term skin compatibility testing
- Signal quality in motion exceeds earlier reference setups (e.g. endurance monitoring use cases)
- Flexible strap design with adjustable fit; product roadmap includes 2–3 standardized sizes
- Final prototype successfully tested on multiple subjects
This validates HeartGuard’s suitability for long-term home monitoring, not just lab conditions.
✔ Research-Ready Data Platform & Interpretation Software
HeartGuard includes a mature data analysis environment:
- Interactive signal visualization (zoom, markers, multi-channel overlays)
- Automated clinical reporting (HRV, ECG morphology, ICG parameters)
- Modular AI pipeline for:
- Cardiac parameters
- Respiration
- Oxygenation
- Temperature
- Activity
This enables rapid clinical research, validation studies, and algorithm development on top of the hardware platform.
✔ Innovation Pipeline (Patent Pending)
- Cuffless blood pressure estimation using combined ICG + PAT — patent pending
- Ongoing development of AI models for:
- Early heart failure decompensation
- Arrhythmia detection
Why This Matters
Unlike many “concept-stage” digital health solutions, HeartGuard is built on:
- Working hardware
- Validated physiological algorithms
- Clinically benchmarked signal processing
- A scalable embedded platform
This means HeartGuard is positioned not as a speculative concept, but as a near-clinical, translational technology platform ready for pilots, clinical studies, and regulated product development.