FDA clears Qure.ai's CAD tool for chest X-rays
The U.S. Food and Drug Administration has cleared a new computer-aided detection (CAD) solution for chest X-rays.
Qure.ai—a health technology company that specializes in AI solutions—announced the class 2 clearance of qXR-Detect on Thursday. The reporting tool is used to highlight findings from plain chest radiographs completed in emergency departments, urgent care clinics and family practices.
Findings flagged by qXR-Detect are categorized into six regions of interest in the chest, including the lungs, pleura mediastinum /hila and heart, bone, hardware and others. It alerts providers of its findings, also directing them to the area of interest and explaining the reasoning behind the alert. This feature helps to expedite the diagnostic process while ensuring critical findings are not overlooked.
The tool was trained on more than 9 million exams, and has since been used to process over 10 million images. Testing revealed that it can reduce reporting turnaround times by up to 40% and it achieves 99% negative predictive value for ruling out unremarkable chest X-rays.
“There are more than 100 potential findings on a plain film chest X-ray that AI tools can help detect and assist radiologists with, supporting earlier recognition of abnormalities,” Amit Gupta, MD, modality director of diagnostic radiography at University Hospitals Cleveland, said in an announcement. “When used alongside standard clinical interpretation, chest radiography augmented with AI-based detection and localization can offer a practical frontline support tool for identifying findings such as lung nodules and other abnormalities that may warrant closer attention or further diagnostic workup.”
Learn more about the product here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.