WHO Adds AI TB X-Ray Screening to Medical Device Review: What Changes?
In brief: On 25 September 2026, WHO said it would expand its medical device prequalification programme to include computer-aided detection (CAD) software used to screen chest X-rays for possible tuberculosis. The change concerns a quality assessment and procurement framework. It does not mean AI can diagnose TB on its own or that a particular product has been approved in every country.
What did WHO expand?
The World Health Organization broadened the scope of medical device prequalification to include CAD software for TB screening, male and female condoms, and intrauterine devices. Male circumcision devices are being brought into its broader medical device framework. The announcement was made on 25 September 2026.
Prequalification provides independent assessment of quality, safety, and performance to guide international procurement by UN agencies, donors, and national authorities. Adding a category to the programme is distinct from listing any particular product as prequalified.
What can AI chest X-ray screening do?
CAD software analyses digital chest X-rays and flags people who may need further testing for TB. WHO highlights its potential relevance in settings with a high TB burden, where dependable screening can help people reach diagnostic services sooner.
Screening is not a diagnosis. An abnormal X-ray can have other causes, and an image alone does not settle a person’s clinical situation. Symptoms, exposure history, further tests, and a clinician’s judgment still matter. A screening score should not be used on its own to start or stop treatment.
Does this authorize a device in my country?
No. WHO prequalification supports procurement decisions; national regulators and health systems separately determine local authorization, availability, and use. In Korea, the approval status of a named medical device requires a product-level check with the Ministry of Food and Drug Safety. Readers in other countries should consult their national regulator. Coverage or reimbursement is also a separate question.
What remains to be checked?
The first assessment wave, the list of products that complete evaluation, and country-specific decisions will need product-level follow-up. This announcement does not establish the accuracy or clinical outcomes of an unnamed AI tool.
Primary source and review
WHO announcement on expanded medical device prequalification (25 September 2026). Sources reviewed 28 September 2026. Prepared by Life Choice Note. General information; medical diagnosis and treatment require a qualified professional. Sources and corrections policy.