New Article Highlights Clinical Perspectives on Wearable Biosensor for Children with Cyanotic Congenital Heart Disease
TEDDY Network is pleased to announce the publication of the peer-reviewed article titled “Clinical perspectives on wearable devices for paediatric cyanotic congenital heart disease: an expert survey to inform the early development of a multiparametric wearable biosensor”, published in Frontiers in Medicine (doi: 10.3389/fmed.2026.1819360).
The study was developed within the OrphaDev4Kids project (EU4H-2023-PJ, Grant Agreement No. 101161377), a European Union co-funded initiative running from 2024 to 2027 and coordinated by the European Paediatric Transnational Research Infrastructure (EPTRI). The project aims to address critical unmet needs in the field of orphan medical devices for paediatric patients through multidisciplinary research and innovation across Europe.
Within this framework, TEDDY Network is responsible for establishing and supporting a Paediatric Experts Committee (PEC) to define the therapeutic needs of children in the project’s clinical case studies. In addition, the TEDDY Network contributes to ethical, legal, and regulatory guidance, supporting the preparation and revision of documentation required for clinical study submissions.
ABOUT THE PUBLICATION
The publication presents results from an expert-based survey, revealed strong clinical interest in wearable devices capable of continuously monitoring multiple physiological parameters through a non-invasive, child-friendly design. Experts emphasized that successful devices must provide meaningful and actionable information rather than overwhelming clinicians with large volumes of raw data.
Among the key priorities identified were:
- Early detection of clinical deterioration during high-risk periods;
- Comfortable and unobtrusive designs suitable for children;
- Easy integration into existing clinical workflows;
- Clear data visualisation and targeted alerts;
- Robust data governance and privacy protections.
The findings also highlighted the importance of involving clinicians early in the development process to ensure that future technologies address real-world clinical needs and can be successfully adopted in practice.
The survey was developed within Work Package 3 (WP3) of the OrphaDev4Kids project, for which IRCCS Eugenio Medea (Italy) serves as Work Package leader, and implemented in collaboration with contributing consortium partners, including Università degli Studi di Bari Aldo Moro (Italy), Children’s Memorial Health Institute (Poland), European Paediatric Transnational Research Infrastructure (Belgium), TEDDY European Network of Excellence for Paediatric Research (Italy), Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus (Italy), and Clinical Validation from Biopharmaceutical Findings (Italy). WP3 focuses on wearable biosensor technologies aimed at preventing lactic acidosis in children with unrepaired congenital heart defects and monitoring physiological responses following pulmonary valve replacement in children with repaired congenital heart defects.
The full article is freely available in Frontiers in Medicine: https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2026.1819360/full