The U.S. Food and Drug Administration (FDA) has cleared Qure.ai's AI CT software qCT LN Quant.
The company announced the clearance at the 2024 American Association for Bronchology and Interventional Pulmonology (AABIP) meeting being held in Charlotte, NC.
The software supports radiologists and pulmonologists in analyzing lung nodules on noncontrast chest CT scans and tracking volumetric growth as part of monitoring disease progression and offers quantitative characterization of solid lung nodules by measuring average, short-axis, long-axis, and effective diameters. qCT LN Quant allows clinicians to analyze morphological data across single or multiple thoracic studies, including estimated volume doubling time and tracking of nodules over several time points.
qCT LN Quant also generates 2D and 3D reconstructions, Brock malignancy risk scores, and Fleischner Society guidelines-based management suggestions to support clinical decision-making. It is potentially eligible under two CPT codes for reimbursement -- tissue quantification CPT 0722T for CT and 3D reconstruction code, Qure.ai said.