Cleerly Labs

Cleerly Labs is a web-based software application that enables medical professionals to analyze CCTA images for the presence and extent of coronary artery disease by providing interactive tools for image visualization, segmentation, and quantification of coronary plaques and stenosis. The system utilizes CT data post-processing with manual and semi-automatic segmentation capabilities to measure vessel dimensions, plaque volumes (including calcified, non-calcified, and low-density non-calcified components), and stenosis, aiming to support clinical decision-making in CAD evaluation.

Cleerly Labs is a web-based software application designed for trained medical professionals to analyze cardiac computed tomography (CT) data. Its primary purpose is to aid in determining the presence and extent of coronary plaques and stenosis in patients who have undergone Coronary Computed Tomography Angiography (CCTA) for evaluation of actual or suspected coronary artery disease (CAD). The software functions as an interactive post-processing tool, capable of handling 2D and 3D coronary images from any CT scanner, and assists clinicians in navigating and manipulating these images to inform treatment paths for CAD patients. The software employs manual and semi-automatic segmentation tools, allowing users to edit lumen and vessel walls, demarcate stenosis and stents, and thus perform detailed coronary analysis. Its outputs include visual representations of coronary arteries, along with quantitative measurements such as distance and volume of the lumen wall, vessel wall, and various plaque types (calcified, non-calcified, low-density non-calcified). It also provides remodeling index, stenosis diameter, and area measurements, all based on user-refined segmentation. Performance data, when compared to expert readers, showed strong Pearson correlation coefficients for lumen volume (0.91), vessel volume (0.93), total plaque volume (0.85), and calcified plaque volume (0.94), with slightly lower correlation for non-calcified (0.74) and low-density non-calcified plaque (0.53), alongside high Bland-Altman agreement percentages for these measures.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. Given the lower Pearson correlation (0.53) for Low-Density Non-Calcified Plaque (LD-NCP) volume compared to other plaque types, what are the specific challenges in its automated or semi-automated quantification, and what steps are being taken to improve this accuracy?; How does the performance of Cleerly Labs' semi-automatic segmentation compare to fully manual segmentation by expert users in terms of time efficiency and inter-observer variability for complex lesions?; The software uses interpolated data for certain views; can you elaborate on the specific scenarios where interpolation is most heavily relied upon and the potential impact on diagnostic accuracy for subtle pathologies near the scanning resolution limit?; What is the defined training protocol for "trained medical professionals" to ensure proficient and consistent use of Cleerly Labs, especially concerning the manual editing and interpretation of semi-automated segmentation results?; Beyond the listed plaque characteristics (CP, NCP, LD-NCP), does Cleerly Labs offer any tools or potential for characterizing other high-risk plaque features, such as positive remodeling or spotty calcification, that are not explicitly quantified in Table 5?