Qure.ai has launched AI-powered chest X-ray tool, qXR, that has received CE Class IIb certification for diagnosing tuberculosis in children aged zero to three years, becoming the first AI solution cleared for this age group. The approval extends qXR’s capabilities for children up to 15 years, offering full paediatric coverage.

Already referenced twice in WHO TB screening guidelines, qXR can now help health systems and national TB programmes identify children at the highest risk of active TB, even when symptoms are not present.

Paediatric TB is a silent crisis that affects children, globally. In 2023, close to 1.3 million children aged under 15 years fell ill with TB, representing about 12 percent of total cases worldwide. Children under five years are particularly vulnerable due to underdeveloped immune systems, bearing the highest burden and accounting for more than 75 percent of TB-related deaths in this age group. Tragically, close to 200,000 children died of TB in 2023, most of them under five. Moreover, drug-resistant TB, including extensively drug-resistant forms, is rising among children, creating an urgent public health challenge.

Diagnosing TB in children is notoriously difficult. Young children often have paucibacillary TB and this is further complicated by their inability to produce sputum, which makes traditional diagnostic methods less reliable and delays treatment. Chest X-rays provide a practical supplement, allowing clinicians to detect TB even when sputum samples are unavailable.

AI-enabled chest X-rays take this a step further. They can screen large numbers of children quickly, prioritise high-risk cases, help detect asymptomatic TB, reduce clinician workload, and deliver immediate, actionable results. By combining the reliability of imaging with AI-driven speed and scalability, health systems can intervene earlier and allocate resources more effectively, ultimately saving lives.

Commenting on the announcement, Dr Shibu Vijayan, Chief Medical Officer (CMO), Global Health, Qure.ai, said, "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."

Additionally, Qure.ai has implemented 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), within the care coordination platform- qTrack from Qure.ai. This functionality enables structured data entry and automated computation of algorithmic parameters to facilitate clinical diagnosis of tuberculosis in children who are bacteriologically negative or unable to undergo microbiological testing.

TB is not confined to low- and middle-income countries. In the WHO European Region, children under 15 years of age accounted for 4.3 percent of new and relapsed TB cases, a 10 percent increase compared to 2022. In the EU/EEA, paediatric TB cases have risen for the third consecutive year. Children are highly vulnerable to severe forms of TB, such as TB meningitis and miliary TB. Also, the window from infection to active disease and severe, disseminated TB is much shorter in children than in adults. Therefore, early detection and prompt treatment are crucial to reducing morbidity, mortality, and transmission.