Qure.ai has received U.S. Food and Drug Administration (FDA) 510(k) clearance for qXR-Detect, its latest computer-assisted detection (CADe) radiography solution.

The tech powers early identification, highlighting and categorizing key positive findings on plain film chest X-rays. This “six-in-one” indication FDA nod completes the qXR suite of AI algorithms, covering the breadth of findings on chest X-rays.

Findings categorized into six regions of interest are added, including lung, pleura, mediastinum/hila and heart, bone, hardware, and others.

“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,” said Professor Amit Gupta, Division Chief of Cardiothoracic Imaging and Modality Director of Diagnostic Radiography at University Hospitals Cleveland Medical Center. “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. 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.”

To gain the FDA clearance, a performance test of qXR-Detect was conducted as a standalone and a multi-reader multi-case (MRMC) clinical study. The device showed good performance in both and met the predefined success criteria.

“These super six indications cleared by the FDA for qXR-Detect establishes Qure.ai as the foremost commercial AI company, with the most comprehensive regulatory clearances for chest X-ray globally,” said Samir Shah, chief medical officer at Qure.ai. “qXR-Detect is also the only chest X-ray CADe device cleared by the FDA with a Predetermined Change Control Plan (PCCP). This will help assure US health system customers access to the most up-to-date version of the algorithm as models and architecture evolves. This new clearance is testimony to the robust FDA regulatory process Qure.ai upholds and an exciting moment for all involved in the quest to create a stage shift in lung cancer.”

Qure.ai’s FDA cleared indications now total 26 across 9 products for X-ray and CT, exceeding 65 CE certified indications and other global validations. In October, the company earned FDA clearance for its qER CTA solution, which analyzes CT angiography (CTA) scans for suspected large vessel occlusions (LVOs) in the brain