CE Mark For India-Made AI For Screening TB In Toddlers

Indian medical imaging AI company Qure.ai has received new European approval to expand the use of its chest X-ray analysis tool for diagnosing paediatric tuberculosis (TB) in toddlers. The company recently obtained a CE Mark under the European Union's Medical Device Regulation, authorizing the use of its AI-powered chest X-ray software, qXR, for children aged 0–3 years.

Last year, Qure.ai enhanced qXR by training it with a larger paediatric dataset—chest X-rays from children aged 0–15 years paired with corresponding GeneXpert results from several high TB-burden countries. “We gathered thousands of these X-rays and retrained the model to capture the subtle and often non-specific patterns seen in younger children, particularly those under five,” explained Divya Gupta, Chief Business Officer – Global Health at Qure.ai. She noted that the updated model showed a marked increase in accuracy across all paediatric groups. Both retrospective and prospective studies conducted after internal validation and deployments at select global sites produced highly encouraging results. The company plans to present findings from a large-scale internal validation at a global lung health conference in Denmark later in November. Preliminary analyses from earlier test sets have already shown a 20% improvement in diagnostic accuracy compared to GeneXpert results after integrating paediatric data into the model.

Qure.ai emphasized that children under five have long been underrepresented in the development of AI tools for TB detection. “The youngest children have long been the hardest to reach and the most vulnerable,” said Dr. Shibu Vijayan, Qure.ai’s Chief Medical Officer. Children under five account for more than 75% of all TB-related child deaths worldwide, and in 2023 alone, most of the nearly 200,000 children who died from TB were in this age group. The increasing prevalence of drug-resistant TB in children makes diagnosis and treatment even more complex.

With the CE MDR certification, Qure.ai plans to pursue broader deployments and collaborations, including securing registrations and regulatory approvals in high TB-burden countries across Africa and Southeast Asia to support national-level programs. The company also aims to partner with child-focused organizations such as Save the Children, the Elizabeth Glaser Paediatric AIDS Foundation, and UNICEF.

Beyond TB, Qure.ai is addressing other paediatric health concerns raised by its clients, including TB severity classification and paediatric pneumonia—both major causes of under-five mortality. The company has also implemented one of the World Health Organization’s treatment decision algorithms within its qTrack care coordination platform, which allows structured data entry and automated calculation of clinical parameters to support TB diagnosis in children. Integrating its screening tool and care coordination system enables healthcare professionals to make more informed, guideline-based decisions even in decentralised or low-resource settings. “Essentially, qXR provides the diagnostic insight, and qTrack ensures the right follow-up and treatment pathway, closing the loop from screening to care,” Gupta said.

Qure.ai is additionally promoting AIRA, its large language model-based AI assistant for community health launched in May. AIRA automates patient data collection, aggregates population-level insights, and helps ensure adherence to clinical protocols and decision-making, reinforcing Qure.ai’s broader commitment to advancing AI-driven healthcare for children.

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