FDA Clears Emerging AI-Powered CXR Software from Qure.ai

The Food and Drug Administration (FDA) has granted 510(k) clearance for the AI software qXR-Detect, which may assist with a variety of findings on chest X-rays.

Qure.ai, the developer of the software, said the FDA clearance for qXR-Detect covers multiple regions of interest including the lung, bone, hila and heart, pleura and mediastinum.

Noting the evolving nature of AI models and architecture, the company pointed out that the FDA clearance includes a Predetermined Change Control Plan (PCCP), which facilitates health system access to the most updated version of the qXR-Detect software.

“Tools such as qXR-Detect go beyond binary detection alone. In addition to flagging potential abnormalities, the system provides visual localization and explainability, such as through bounding boxes and region-of-interest labels, which helps the interpreting radiologist quickly understand where and why an alert has been generated,” noted Amit Gupta, M.D., the division chief of cardiothoracic imaging and modality director of diagnostic radiography at University Hospitals Cleveland Medical Center.