WHO Adds AI-Powered TB Screening to Medical Device Prequalification

The World Health Organization has expanded its medical device prequalification program, adding contraceptives, AI-powered tuberculosis screening tools and other essential medical devices. It is the first time a digital health technology powered by artificial intelligence has entered the program.

The computer-aided detection (CAD) software analyzes digital chest X-rays using AI algorithms to flag individuals who may have TB and require further diagnostic testing. Prequalification gives UN agencies and low- and middle-income countries a vetted list of products they can procure with confidence.

Including AI diagnostics signals the WHO's recognition that digital health technologies will play an increasingly important role in global health, and that quality-assurance frameworks must evolve to keep pace with innovation.

The organization has published details on the transition process, next steps and the first assessment wave, which covers contraceptive devices, CAD-TB products and male circumcision devices. For AI screening tools, prequalification provides a pathway to scale in exactly the settings that lack radiologists — while keeping an evidence bar in place.