Periodic Reporting for period 2 - VR-CARDIO (VISUALIZACIÓN DE BIOPOTENCIALES PARA EQUIPOS CARDIOLÓGICOS)
Reporting period: 2023-07-01 to 2025-06-30
Cardiac arrhythmias are among the leading causes of morbidity and hospital admissions in Europe, with complex and costly diagnostic procedures often requiring invasive imaging, prolonged hospital stays, and specialist expertise. VR-CARDIO addresses these challenges by introducing a new, non-invasive software solution that reconstructs electro-anatomical heart maps directly from body surface ECG signals.
The system is designed to support cardiologists in diagnosing and planning treatment of arrhythmias, especially atrial fibrillation (AF), by offering a fast, accurate, and radiation-free alternative to conventional mapping. Using machine learning and signal analysis, VR-CARDIO builds 3D cardiac activation maps without the need for CT or MRI, and displays them through immersive technologies such as virtual reality (VR), augmented reality (AR), and holographic projections.
Initially developed with a proprietary textile-based Data Acquisition System (DAS), the project evolved toward a hardware-independent software platform, compatible with existing ECG infrastructure in hospitals. This decision significantly reduces deployment barriers and accelerates clinical adoption.
VR-CARDIO contributes to broader EU goals by improving patient care, supporting medical workforce efficiency, and lowering healthcare costs. It is also aligned with the EU Medical Device Regulation (MDR 2017/745), and is undergoing CE certification as a Class IIb medical device, expected in July 2025. The project supports innovation in digital health, strengthens European leadership in medtech, and improves access to advanced cardiac diagnostics across multiple healthcare settings.
The system is designed to support cardiologists in diagnosing and planning treatment of arrhythmias, especially atrial fibrillation (AF), by offering a fast, accurate, and radiation-free alternative to conventional mapping. Using machine learning and signal analysis, VR-CARDIO builds 3D cardiac activation maps without the need for CT or MRI, and displays them through immersive technologies such as virtual reality (VR), augmented reality (AR), and holographic projections.
Initially developed with a proprietary textile-based Data Acquisition System (DAS), the project evolved toward a hardware-independent software platform, compatible with existing ECG infrastructure in hospitals. This decision significantly reduces deployment barriers and accelerates clinical adoption.
VR-CARDIO contributes to broader EU goals by improving patient care, supporting medical workforce efficiency, and lowering healthcare costs. It is also aligned with the EU Medical Device Regulation (MDR 2017/745), and is undergoing CE certification as a Class IIb medical device, expected in July 2025. The project supports innovation in digital health, strengthens European leadership in medtech, and improves access to advanced cardiac diagnostics across multiple healthcare settings.
Over the course of the project, VR-CARDIO was designed, implemented, validated, and industrialised. The software underwent a full clinical and technical validation cycle, confirming its ability to generate 3D cardiac maps from ECG signals in real-world settings. Pilot studies were conducted with cardiologists and electrophysiologists in Spain, demonstrating the system’s accuracy and usability.
Technical work included signal processing, artefact correction, and anatomical mapping algorithms. The system showed strong performance in locating AF triggers without relying on invasive methods. A proprietary DAS was also developed with 34 textile electrodes, validated through laboratory and safety testing. Although not part of the certified product, this DAS is ready for future deployment.
The project also developed a scalable business model, shifting to a software-as-a-service (SaaS) model with flexible deployment options. Certification activities advanced significantly: the software passed its CE audit. Spika Tech obtained ISO 13485 and 27001 certifications and is registered with AEMPS as a medical device manufacturer.
All deliverables and milestones were met or updated to reflect regulatory changes. The system is now TRL 8-validated and ready for commercialisation after CE approval.
Technical work included signal processing, artefact correction, and anatomical mapping algorithms. The system showed strong performance in locating AF triggers without relying on invasive methods. A proprietary DAS was also developed with 34 textile electrodes, validated through laboratory and safety testing. Although not part of the certified product, this DAS is ready for future deployment.
The project also developed a scalable business model, shifting to a software-as-a-service (SaaS) model with flexible deployment options. Certification activities advanced significantly: the software passed its CE audit. Spika Tech obtained ISO 13485 and 27001 certifications and is registered with AEMPS as a medical device manufacturer.
All deliverables and milestones were met or updated to reflect regulatory changes. The system is now TRL 8-validated and ready for commercialisation after CE approval.
VR-CARDIO introduces a novel, non-invasive method for generating electro-anatomical heart maps using ECG data alone, eliminating the need for CT or MRI imaging. The software reconstructs cardiac activation in 3D, providing clinicians with fast, precise insights into arrhythmia mechanisms—without the risks or cost of invasive procedures.
Its hardware-agnostic design allows seamless integration into existing hospital ECG infrastructure, expanding access and reducing deployment complexity. The system uses a predefined anatomical atlas, avoiding external imaging dependencies. It includes validated signal analysis, machine learning models, and intuitive 3D visualisation interfaces.
During the project, Spika Tech secured European patent protection for VR-CARDIO (EP23382800), achieved key certifications (ISO 13485, ISO 27001), and is close to obtaining CE marking under MDR 2017/745. Demonstration activities confirmed interoperability, clinical utility, and regulatory readiness.
To support market uptake, a modular SaaS pricing strategy was defined, targeting cardiology and emergency care settings. The commercial rollout will start in Spain, followed by European and US expansion.
Next steps include completing CE certification, expanding clinical validation, and initiating international regulatory pathways (FDA, JFDA). The project demonstrates how advanced signal processing, AI, and immersive technologies can converge to transform cardiac diagnostics.
Its hardware-agnostic design allows seamless integration into existing hospital ECG infrastructure, expanding access and reducing deployment complexity. The system uses a predefined anatomical atlas, avoiding external imaging dependencies. It includes validated signal analysis, machine learning models, and intuitive 3D visualisation interfaces.
During the project, Spika Tech secured European patent protection for VR-CARDIO (EP23382800), achieved key certifications (ISO 13485, ISO 27001), and is close to obtaining CE marking under MDR 2017/745. Demonstration activities confirmed interoperability, clinical utility, and regulatory readiness.
To support market uptake, a modular SaaS pricing strategy was defined, targeting cardiology and emergency care settings. The commercial rollout will start in Spain, followed by European and US expansion.
Next steps include completing CE certification, expanding clinical validation, and initiating international regulatory pathways (FDA, JFDA). The project demonstrates how advanced signal processing, AI, and immersive technologies can converge to transform cardiac diagnostics.