Diagnosing tuberculosis (TB) in children has long posed significant challenges, especially among the youngest age groups where symptoms are often non-specific and microbiological confirmation is difficult. However, this landscape is beginning to change. Mumbai-based healthtech startup Qure.ai has achieved a major milestone with its AI-powered chest X-ray interpretation tool, qXR, becoming the first of its kind to receive CE Class IIb certification for children aged 0–3 years. This builds on its existing clearance for children up to 15 years, effectively extending diagnostic support across the entire paediatric age spectrum.
Paediatric TB remains a silent global health crisis. According to 2023 estimates, nearly 1.3 million children under 15 years fell ill with TB, accounting for about 12% of total global cases. Children below five years are especially vulnerable due to immature immune systems, carrying the heaviest burden and representing over 75% of TB-related deaths in this group. Alarmingly, around 200,000 children lost their lives to TB in 2023, with most deaths occurring among those under five. Compounding this crisis is the growing threat of drug-resistant TB, including extensively resistant forms, which is increasingly being detected in paediatric populations worldwide.
Highlighting the significance of this regulatory approval, Dr Shibu Vijayan, Chief Medical Officer, Global Health at Qure.ai, stated, “Achieving CE clearance for AI-enabled Chest X-ray screening in children is a major step forward in the fight against paediatric TB. The youngest children have long been the hardest to reach and the most vulnerable. With this tool, we are proud to equip healthcare systems worldwide with a scalable, reliable way to detect TB early, prioritise care, and ultimately save lives.”
In addition to the qXR milestone, Qure.ai has further strengthened its TB management ecosystem by integrating the Treatment Decision Algorithm A (TDA)—as outlined in the WHO Consolidated Guidelines on Tuberculosis: Module 5 – Management of Tuberculosis in Children and Adolescents (2022)—into its care coordination platform, qTrack. This integration supports structured data entry and automated computation of clinical parameters, enabling clinicians to make informed diagnostic decisions for children who test bacteriologically negative or cannot undergo microbiological testing.
Together, qXR and qTrack represent a significant leap toward scalable, AI-driven paediatric TB detection and management, addressing one of the most pressing and under-recognised challenges in global child health.