WHO opens assessment to AI-assisted TB screening and more contraceptive devices

The process examines the particular device, its manufacture and its continuing performance.

The expanded scope includes computer-aided detection software used with chest X-rays for tuberculosis screening, alongside male latex condoms, female condoms and copper-bearing intrauterine devices. Contraceptive-device assessment moves from UNFPA into WHO’s framework; male circumcision devices, already assessed through a separate process, are also included. The news concerns eligibility and an assessment route, not a blanket declaration that every relevant product has qualified.

For AI screening software, that boundary is especially important. A model can assign an abnormality score to an X-ray and help decide who should receive further diagnostic evaluation. Such a score is not a diagnosis of tuberculosis. Its usefulness depends on the intended population, the chosen threshold and the availability of the next step in care.

WHO’s process examines product evidence and manufacturing quality systems, with oversight continuing after prequalification. This gives developers a more explicit quality pathway and purchasers a basis for comparing the status of individual products. Whether it ultimately improves access or patient outcomes will depend on implementation, not just the publication of a framework.

Teams developing or procuring CAD-TB software can start with two separate resources: the current prequalification scope and WHO’s existing local-calibration toolkit. The first asks whether a product can enter the assessment process. The second helps an implementer investigate how its threshold should be used in a particular screening setting. Both questions need an answer.