POUYA-Heart: AI-Enabled Phonocardiography for Scalable Paediatric and Neonatal Cardiac Screening

POUYA-Heart is a clinically validated AI-enabled medical device designed to enable scalable, non-invasive screening of congenital heart disease (CHD) in newborns and children up to 12 years of age, addressing a major and persistent gap in cardiovascular care.

CHDs represent the leading cause of malformation-related mortality in children and a major contributor to lifelong cardiovascular disease. Despite routine screening, more than 50% of CHDs remain undetected at maternity discharge, and milder or atypical defects are frequently missed during early childhood. These delayed diagnoses contribute to preventable complications, increased healthcare costs, and a rapidly growing population of adults with congenital heart disease (ACHD), placing sustained pressure on healthcare systems across the life course.

The POUYA-Heart solution

POUYA-Heart is an intelligent phonocardiograph based on a patented mathematical model of spectral analysis of neonatal and paediatric heart sounds, combined with AI algorithms. The system enables:

• Rapid, fully non-invasive cardiac screening with AI-based detection of pathological heart sounds beyond human audibility

• Automatic classification of physiological vs pathological murmurs

• Applicability across neonatal and paediatric populations (0–12 years)

• Simple, standardised operation by nurses and midwives (sages-femmes) with minimal training

• Scalable use across clinical and non-clinical settings, including maternity wards, paediatric clinics, schools, and community health programmes

Clinical validation and readiness for scale-up

The technology has been evaluated through prospective, multicentric, double-blind clinical studies conducted in Iran and India, involving thousands of newborns and children, demonstrating:

• High diagnostic performance, with sensitivity, specificity, and accuracy exceeding 98%, outperforming routine auscultation and pulse oximetry

• Robust and consistent performance across different age groups (neonates to children) and diverse clinical environments

These results position POUYA-Heart as a mature innovation ready for large-scale deployment within European health systems.

Current collaborations and project context

POUYA-Heart is currently being further developed and validated within a Win2Wal-funded project, in collaboration with the Université de Mons (UMONS) and CHU Helora – Hôpital de Mons.

This ongoing European collaboration focuses on:

• optimising device usability in clinical and non-clinical environments through AI-based signal processing, including improved handling of ambient acoustic noise (targeting routine settings, including noisier environments such as schools, up to ~55 dBA),

• European clinical validation and workflow integration, enabling routine use in neonatal and paediatric care by nurses and midwives (sages-femmes).

Partners sought

At this stage, the project is not seeking methodological or technology-development partners, but is looking for European settings where POUYA-Heart can be used and evaluated within routine care and preventive frameworks, including:

• Hospitals and maternity wards

• Paediatric clinics and outpatient centres

• Schools and school health services

• Preventive and public health programmes

Partners would contribute by providing European use contexts, feedback on implementation within European healthcare and school systems, and potential participation in pilot deployment or observational studies, supporting future scale-up of paediatric cardiovascular screening in Europe.