Cognita CXR AI wins FDA breakthrough device status

Mosaic Clinical Technologies’ Cognita CXR, an Artificial Intelligence model for chest x-ray interpretation, has received breakthrough device designation from the U.S. Food and Drug Administration. The designation is intended for technologies that may provide more effective treatment or diagnosis for life threatening or irreversibly debilitating conditions, highlighting the perceived potential of the software in clinical radiology workflows.

The Cognita CXR software analyzes chest x-rays and generates preliminary findings that licensed radiologists review and finalize, according to the company. Internal clinical validation showed that radiologists using Cognita CXR achieved enhanced detection ranging from 16% to 65% for certain findings and an 18% boost in average interpretation efficiency, Mosaic said. The workflow is designed to keep radiologists in control of final diagnoses while using Artificial Intelligence to flag abnormalities and streamline reading.

Cognita operates as the Artificial Intelligence business unit of Mosaic Clinical Technologies, which is a subsidiary of Radiology Partners. The breakthrough device designation positions Cognita CXR within a growing segment of chest imaging tools that use Artificial Intelligence to improve accuracy and throughput, and it underscores Radiology Partners’ strategy to develop and deploy in-house software to support its network of practices.