SmartCHF-AI – Smart Wearable and Federated AI Ecosystem for CHF Management

SmartCHF-AI aims to be a next-generation digital health solution that integrates a smart wearable device with a federated AI to deliver continuous monitoring and personalised, predictive care for patients with Congestive Heart Failure (CHF). TRAQBEAT wearables are able to capture multimodal physiological data—such as ECG (3-lead), SpO2, HR, HRV, Temperature (core/skin), Respiratory Rate, Blood Pressure, and activity levels—and securely transmits it for real-time analytics and risk assessment. By enabling AI model training across distributed healthcare institutions without transferring raw data, the federated learning architecture safeguards patient privacy while supporting the development of robust, explainable predictive models. These models will further facilitate early detection of CHF decompensation and other cardiovascular events, empowering clinicians to make timely, data-driven interventions. Incorporating synthetic data generation will also ensure inclusivity and model generalisability, particularly for underrepresented populations or data-scarce regions. SmartCHF-AI directly advances the adoption of personalised medicine by tailoring clinical decision-making to individual health profiles, while fostering cross-European collaboration through a secure infrastructure that enables shared AI development and validation. The system promotes knowledge exchange and interoperability across regions via federated model and data catalogues, and supports the scalable deployment of cutting-edge health technologies in cardiology and digital therapeutics. To ensure clinical reliability, safety, and trust, SmartCHF-AI will undergo rigorous conformity assessment under the European Medical Device Regulation (MDR 2017/745). Both the wearable device and its AI-powered predictive components will be developed and documented in accordance with applicable MDR classification rules, particularly those concerning software intended for medical purposes and continuous monitoring of vital physiological processes. The project will also include a dedicated work stream for pre-market certification strategy, technical documentation, clinical evaluation, and alignment with harmonised standards (e.g., ISO 13485, IEC 62304, and ISO 14155), ensuring that the system meets essential requirements for CE marking and eventual integration into clinical workflows across Europe. Aligned with the goals of the Smart Specialisation Strategy (S3) and the S3 Community of Practice, SmartCHF-AI strengthens regional innovation capacity, supports the MDR-compliant scale-up of trustworthy medical AI solutions, and addresses Europe’s collective challenges in cardiovascular care through a human-centric, innovation-driven health ecosystem. Towards these streams TRAQBEAT Technologies PC is a fast-growing company with acknowledged excellence in conducting high-level research and development of innovative systems and services within the context of the Strategic Research & Innovation Agenda for Personalised Medicine (SRIA) - focusing on personalised medicine, and also aligns its goals and innovation with the New European Innovation Agenda (NEIA) and the Smart Specialisation Strategies (S3). Its activities focus on the development of methods and tools in the area of medical sensing and informatics, e-health, m-Health, and Internet of Medical Things. Our goal is to develop a novel, patented, convertible, wearable health tracking device, operating both in and out of the clinic with seamless transition, including AI risk assessment methods capable of providing continuous & synchronous recording of multiple health related biomarkers.