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Broncholab provides physicians with reproducible CT values for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used to support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis, fissure evaluation and reporting tools are combined with a dedicated workflow.

Broncholab is a SaMD (Software as Medical Device) which provides quantitative CT values that are intended to support the physician in the diagnosis and documentation of pulmonary tissues images (abnormalities) from CT scans. The CT scan images are transformed into 3D models of the patient-specific lungs using several image processing steps. Broncholab can be used to assess the effectiveness of therapy based on CT scan data. It is used along with the following accessories: - Web Portal: Enables the uploading of CT scans and patient data - Client Report: Enables the conversion of the output of Broncholab (CT values) into a desired digital format (PDF Report) and transfers this Report to the physician via email. Inspiratory CT scan images uploaded by the users are converted into quantitative CT values using a combination of software tools. Quality checks (both manual and automated) are implemented to assure the quality of the final data. The outputs are provided as absolute values and as a percentage of the total airway volume/ lobar volume depending on the parameter. The device can be used on a computer with a web browser installed and consists of two accessories: - An online portal to upload the CT scans - An accessory that enables the creation of the Report The CT values include: - 1. Lung and Lobar Volume is the volume of the 3D model of each lung lobe. - 2. Airway Volume is defined as the region from the trachea until the segmental bronchi. - 3. Lung Density Scores/ Volumes is defined as all the intrapulmonary voxels with Hounsfield Units between -1024 and -950 using the inspiratory scans: - Low attenuation areas below -950 HU (LAA-950HU) - 15th percentile of density histogram : Percentile density (PD) can also be used to express Emphysema. - Blood vessel density : Blood vessel density can be determined through segmentation and 3-D reconstruction of the blood vessels. The segmentation is based on local geometry features and HU thresholds and is performed on the inspiratory CT scan. - 4. Fissure Analysis (fissure integrity) is the percentage of the fissure. Lung fissures are a doublefold of visceral pleura that either completely or incompletely separates the lungs into lung lobes. CT scan images must be DICOM 3.0 compliant.