AI company Qure.ai has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for qXR-Detect, a computer-assisted detection (CAD) solution for plain film chest x-rays.
The software identifies, highlights, and categorizes positive findings across six regions of interest -- lung, pleura, mediastinum/hila and heart, bone, hardware, and other findings -- to support emergency room physicians, family medicine practitioners, and radiologists, according to the company.
The clearance completes Qure.ai's full qXR product suite and brings its total FDA-cleared indications to 26 across nine x-ray and CT products, the firm said. qXR-Detect also includes a predetermined change control plan, which allows the algorithm to be updated as models evolve without requiring additional clearance, Qure.ai said.
