FDA Grants Breakthrough Device Status to Cognita’s Chest X-Ray AI

The U.S. Food and Drug Administration has granted Breakthrough Device designation to the Cognita Chest X-Ray (CXR) model, developed by Cognita, the AI division of Mosaic Clinical Technologies. The system is designed to assist radiologists in interpreting chest X-ray images across several critical clinical indications.

Cognita CXR uses a vision-language model to analyse chest X-ray images and generate preliminary radiology findings. These results are then reviewed and finalised by licensed radiologists, enabling integration into existing clinical workflows.

Internal validation studies suggest the tool could improve diagnostic performance and efficiency. Radiologists using the system showed 16% to 65% higher detection rates for certain significant findings, while interpretation efficiency increased by about 18%.

The FDA’s breakthrough device programme supports technologies that may significantly improve care for serious conditions by providing closer regulatory collaboration and faster review pathways. Mosaic expects the designation will help address radiology capacity challenges within the US healthcare system.

09-03-2026