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.
![Images show the pectoralis muscles of a healthy male individual who never smoked (age, 66 years; height, 178 cm; body mass index [BMI, calculated as weight in kilograms divided by height in meters squared], 28.4; number of cigarette pack-years, 0; forced expiratory volume in 1 second [FEV1], 97.6% predicted; FEV1: forced vital capacity [FVC] ratio, 0.71; pectoralis muscle area [PMA], 59.4 cm2; pectoralis muscle volume [PMV], 764 cm3) and a male individual with a smoking history and chronic obstructive pulmonary disorder (COPD) (age, 66 years; height, 178 cm; BMI, 27.5; number of cigarette pack-years, 43.2, FEV1, 48% predicted; FEV1:FVC, 0.56; PMA, 35 cm2; PMV, 480.8 cm3) from the Canadian Cohort Obstructive Lung Disease (i.e., CanCOLD) study. The CT image is shown in the axial plane. The PMV is automatically extracted using the developed deep learning model and overlayed onto the lungs for visual clarity.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/03/genkin.25LqljVF0y.jpg?auto=format%2Ccompress&crop=focalpoint&dpr=2&fit=crop&h=167&q=70&w=250)
