Periodic Reporting for period 2 - WILLEM: AI to Reduce Cardiovascular Diseases (WILLEM: AI to Reduce Cardiovascular Diseases)
Okres sprawozdawczy: 2023-11-01 do 2025-04-30
The Willem project, funded under the EIC Accelerator programme, addresses the global burden of cardiovascular diseases (CVDs), which remain the leading cause of mortality worldwide. The project introduces a transformative solution: a fully automated, cloud-based platform for electrocardiogram (ECG) analysis powered by advanced artificial intelligence (AI). Willem is designed to identify and classify all known arrhythmias, thereby enabling earlier diagnosis, improved clinical outcomes, and significant cost reductions for healthcare systems.
At the core of Willem lies a proprietary AI engine trained on one of the world’s most comprehensive and diverse ECG databases. This database includes both healthy and pathological cases, enabling the development of robust models capable of detecting 22 arrhythmias with over 90% accuracy. The platform’s predictive capabilities, particularly for atrial and ventricular fibrillation, represent a pioneering advancement in the field, with no comparable models currently available in the scientific literature.
The project has successfully advanced through key technological milestones, including the optimisation of AI models, integration with third-party eHealth platforms, and the development of a user-friendly medical interface. Clinical validation has been conducted in collaboration with the HM Hospitals and the clinical trial has recruited up to date a total of 22,482 patients across multiple European centres (Spain and The Netherlands), significantly exceeding the initial target of 5,342 patients. These studies have demonstrated Willem’s diagnostic performance, usability, and cost-effectiveness, supporting its CE marking as a Class IIa medical device and paving the way for FDA clearance.
Willem’s architecture is hardware-agnostic, ensuring compatibility with a wide range of ECG devices and seamless integration into existing clinical workflows. This flexibility is critical for adoption by large healthcare providers, pharmaceutical companies, and eHealth platform vendors. The platform’s modular design also supports customisation and white-labelling, enhancing its commercial appeal and scalability across diverse healthcare environments.
From a commercial perspective, Idoven is focused on 12 lead rest disease detection algorithms. Willem is the core ECG analysis for analysing cardiac patterns that is used by healthcare professionals to help speed up the performance and precision of ECG interpretation and diagnosis of cardiac conditions. Idoven is positioning itself to offer the world’s most advanced AI-Powered SaMD solution to speed up the timely identification of CVDs and prevent life threatening injury by improving the performance and precision of ECG interpretation.
In conclusion, the Willem project exemplifies a high-impact, deep-tech innovation with the potential to redefine cardiac diagnostics. By combining scientific excellence, clinical validation, and a robust commercial strategy, Willem not only addresses critical unmet needs in cardiovascular care but also contributes to broader societal goals, including the reduction of premature mortality and the digital transformation of healthcare systems.
At the core of Willem lies a proprietary AI engine trained on one of the world’s most comprehensive and diverse ECG databases. This database includes both healthy and pathological cases, enabling the development of robust models capable of detecting 22 arrhythmias with over 90% accuracy. The platform’s predictive capabilities, particularly for atrial and ventricular fibrillation, represent a pioneering advancement in the field, with no comparable models currently available in the scientific literature.
The project has successfully advanced through key technological milestones, including the optimisation of AI models, integration with third-party eHealth platforms, and the development of a user-friendly medical interface. Clinical validation has been conducted in collaboration with the HM Hospitals and the clinical trial has recruited up to date a total of 22,482 patients across multiple European centres (Spain and The Netherlands), significantly exceeding the initial target of 5,342 patients. These studies have demonstrated Willem’s diagnostic performance, usability, and cost-effectiveness, supporting its CE marking as a Class IIa medical device and paving the way for FDA clearance.
Willem’s architecture is hardware-agnostic, ensuring compatibility with a wide range of ECG devices and seamless integration into existing clinical workflows. This flexibility is critical for adoption by large healthcare providers, pharmaceutical companies, and eHealth platform vendors. The platform’s modular design also supports customisation and white-labelling, enhancing its commercial appeal and scalability across diverse healthcare environments.
From a commercial perspective, Idoven is focused on 12 lead rest disease detection algorithms. Willem is the core ECG analysis for analysing cardiac patterns that is used by healthcare professionals to help speed up the performance and precision of ECG interpretation and diagnosis of cardiac conditions. Idoven is positioning itself to offer the world’s most advanced AI-Powered SaMD solution to speed up the timely identification of CVDs and prevent life threatening injury by improving the performance and precision of ECG interpretation.
In conclusion, the Willem project exemplifies a high-impact, deep-tech innovation with the potential to redefine cardiac diagnostics. By combining scientific excellence, clinical validation, and a robust commercial strategy, Willem not only addresses critical unmet needs in cardiovascular care but also contributes to broader societal goals, including the reduction of premature mortality and the digital transformation of healthcare systems.
The project has started with the optimization of new WILLEM’s processes for cardiac arrhythmia classification, detection, and prediction, to improve WILLEM scope as a medical software according to CE marking Regulation (EU) and the FDA Clearance (US).
In parallel, IDOVEN has also been working in the implementation, integration and testing of a full cloud-based platform for non-supervised real-time SaaS ECG analysis. There has been started too, the personalization of API tools to seamlessly integrate WILLEM with third-party digital platforms.
Finally, dissemination and communication activities have beel also started, with the project presentation and marketing material elaboration and preliminary analysis for IPR protection and any other legal aspect related to project work.
In parallel, IDOVEN has also been working in the implementation, integration and testing of a full cloud-based platform for non-supervised real-time SaaS ECG analysis. There has been started too, the personalization of API tools to seamlessly integrate WILLEM with third-party digital platforms.
Finally, dissemination and communication activities have beel also started, with the project presentation and marketing material elaboration and preliminary analysis for IPR protection and any other legal aspect related to project work.
Thanks to the EIC Project, WILLEM will become a TRL9 SaaS with the highest arrhythmia identification, classification and prediction capabilities on the market with medical-grade accuracy. Its hardware-agnostic capabilities and its ability to integrate with other eHealth platforms, mainly through APIs, will enable hundreds of thousands of ECGs in a fully scalable way and without
the need for human supervision.
It is estimated that the average price of a 7-day ECG without human supervision and in real time (or less than 8 minutes) will be 10 euros, with an operating cost of 2 euros and 8 euros of margin.
The exponential growth of the project will come from massive ECG processing with very low operational costs.
If IDOVEN does not get the EIC Accelerator, our European digital Health market will be predictably dominated by US companies. China, with the largest number of patents on AI for ECG analysis, will bet on the European market and on the health data of European citizens.
the need for human supervision.
It is estimated that the average price of a 7-day ECG without human supervision and in real time (or less than 8 minutes) will be 10 euros, with an operating cost of 2 euros and 8 euros of margin.
The exponential growth of the project will come from massive ECG processing with very low operational costs.
If IDOVEN does not get the EIC Accelerator, our European digital Health market will be predictably dominated by US companies. China, with the largest number of patents on AI for ECG analysis, will bet on the European market and on the health data of European citizens.