AI Powered Neurovascular Health Monitoring

This project aims to define and implement the regulatory roadmap for clinical validation of an innovative digital health solution for stroke prevention, developed through the collaboration between the Stroke Pharmacogenomics and Genetics group at the Sant Pau Hospital Research Institute and the Barcelona Supercomputing Center (BSC) spinoff OneCareAI. OneCareAI, established in April 2025, integrates electrical signal fingerprints (e.g., ECG from wearable devices) with biological signal fingerprints (e.g., multi-omics biomarkers) to identify individuals at high risk of stroke. The partnership is currently executing a pilot study focusing on cardioembolic stroke under the Generalitat de Catalunya's "AGAUR Producte" funding, while BSC also leads the EU-funded INNOSTROKE project focused on the development of the supporting technological platform (mobile app, dashboard, and clinical registry). The proposed project will focus on preparing the necessary steps to achieve CE marking and regulatory approval for the OneCareAI product, enabling its clinical deployment and commercialization. Over 24 months, we will carry out: (1) the definition of a regulatory-compliant clinical study design; (2) a market and regulatory landscape analysis to ensure alignment with EU MDR, AI Act, GDRP and digital health requirements; (3) prospective clinical validation at Sant Pau Hospital; and (4) final submission to the relevant regulatory bodies. The expected outcomes include a validated clinical study protocol, risk classification documentation, usability and safety data, and a complete regulatory dossier. This initiative directly aligns with PRECISEU's objectives by promoting personalized prevention through AI-based, clinically integrated solutions, and by supporting early-stage innovation in precision medicine with high potential for patient impact.