News dated
On 25 September, WHO expanded its prequalification programme to new categories of medical devices, including software for tuberculosis screening. This opens an assessment pathway; it does not approve every product automatically. [1]
Prequalification means checking quality, safety and performance. The process reviews documentation and manufacturing systems and includes continuing oversight: it helps guide health procurement towards assessed products. [2]
Screening software analyses chest X-rays and flags possible abnormalities. A flag requires further investigation: it is not, by itself, a diagnosis. Settings also need adjustment for the context in which the software is used. [3]
The bright side
A shared assessment provides a reference for health systems with limited resources to check every device independently. [2]
One idea, in simple words
Before using a tool for health care, people need to check that it works properly. On 25 September, WHO, the World Health Organization, expanded a programme that assesses some medical devices. This does not mean every product has already been approved. [1]
The assessment checks quality, safety and performance. Here is an example from our editors: imagine a weighing scale. If it shows the wrong numbers, even an easy-to-use tool can give wrong information. Health devices need much more detailed checks. [2]
The new categories include programs that help look for signs of tuberculosis, a disease, in chest images. Finding a possible sign is not enough to say someone has the disease: other checks are needed. The computer offers help, not a final answer. [3]
A little discovery to keep
What did you discover?
Straight from the source.
- WHO announces expansion of prequalification programme for medical devices World Health Organization · 25 Sept 2026
- About Medical Device Prequalification World Health Organization · No publication date provided
- Calibrating computer-aided detection (CAD) for TB WHO / TDR · No publication date provided
Original reporting summaries prepared with AI assistance and accessible sources. Our editorial method.
