Mosaic Clinical Technologies’ Cognita AI Model Earns FDA Breakthrough Device Designation

Mosaic Clinical Technologies’ AI unit, Cognita, has received the U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its Cognita Chest X-Ray (CXR) model, a generative vision-language system designed to assist radiologists in interpreting chest X-rays.

The designation allows Cognita to engage in prioritized communication with the FDA as it seeks clearance for the model. Cognita CXR uses an AI architecture that generates comprehensive preliminary findings for radiologists to review, integrating directly with existing radiology workflows rather than flagging isolated findings.

Preliminary internal validation showed radiologists using Cognita CXR achieved up to 65% improved detection of certain findings and an 18% increase in interpretation efficiency. The company said the system aims to address capacity challenges in radiology by improving diagnostic accuracy and workflow efficiency.

Mosaic Clinical Technologies, a subsidiary of Radiology Partners, operates Cognita as its AI business unit. The model will form part of the MosaicOS platform, which supports diagnostic imaging across the Radiology Partners network. The designation from the U.S. Food and Drug Administration (FDA) applies to multiple critical indications and is intended to accelerate development of technologies that could significantly improve patient care.