Indian health-tech innovator Qure.ai has achieved a major milestone with its AI-based chest X-ray screening tool for tuberculosis (TB) in children receiving CE Class IIb certification in Europe. The approval marks a breakthrough in the use of artificial intelligence for early and accurate TB detection in pediatric populations, a group often underdiagnosed due to the complex nature of the disease’s presentation in children.

Qure.ai’s AI solution, an extension of its widely deployed qXR platform, is now approved for use across European Economic Area (EEA) countries, enabling healthcare providers to leverage AI-driven diagnostics for rapid, radiation-efficient, and scalable TB screening in children aged below 15 years.

Speaking on the achievement, Prashant Warier, Founder and CEO of Qure.ai, said, “This approval is a validation of our commitment to making healthcare more equitable and accessible. Pediatric TB remains one of the most underdiagnosed conditions globally, and with this certification, we can empower clinicians to detect it faster and with greater accuracy.”

The European approval follows extensive clinical validation studies across multiple countries, where the AI tool demonstrated high sensitivity and specificity in detecting radiological signs of TB, even in cases where traditional readings were inconclusive.

Experts note that pediatric TB diagnosis often relies on symptom-based assessments and sputum tests, which can be unreliable in younger children. Qure.ai’s AI-powered screening tool bridges this gap by offering an objective, image-based diagnostic support system, particularly beneficial in low-resource and high-burden settings.

The CE certification also positions Qure.ai as one of the first AI healthcare companies globally to secure regulatory approval for pediatric TB detection, reinforcing India’s growing influence in the global medtech innovation landscape.

Qure.ai’s TB screening tools are already being used by global health organizations, including WHO-endorsed programs and national TB control initiatives, across Asia, Africa, and Latin America.

With this European approval, Qure.ai aims to expand its impact further — helping countries strengthen their tuberculosis elimination goals through AI-driven, child-friendly diagnostic solutions.