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The AutoChamber software is an opportunistic AI-powered quantitative imaging tool that measures and reports cardiac chambers volumes comprising left atrium (LA), left ventricle (LV), right atrium (RA), right ventricle (RV), and left ventricular wall (LVW) from non-contrast chest CT scans including coronary artery calcium (CAC) scans and lung CT scans. AutoChamber is not intended to rule out the risk of a cardiovascular disease, and the results should not be used for any purpose other than to enable physicians to investigate patients that AutoChamber shows signs of enlarged heart (cardiomegaly), enlarged cardiac chambers, and left ventricular hypertrophy (LVH) whose conditions are otherwise missed by human eyes in non-contrast chest CT scans. AutoChamber similarly measures and reports LA, LV, RA, RV, and LVW in contrast-enhanced coronary CT angiography (CCTA) scans. Additionally, AutoChamber measures and reports cardiothoracic ratio (CTR) in both contrast and non-contrast CT scans where the entire thoracic cavity is in the axial field of view. AutoChamber quantitative imaging measurements are adjusted by body surface area (BSA) and are reported both in cubic centimeter volume (cc) and percentiles by gender using reference data from 5830 people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA). AutoChamber should not be ordered as a standalone CT scan but instead should be used as an opportunistic add-on to existing and new CT scans of the chest, such as CAC and lung CT scans, as well as CCTA scans. Using AutoChamber quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate asymptomatic patients who are unaware of their risk of heart failure, atrial fibrillation, stroke and other life-threatening conditions associated with enlarged cardiac chambers, and LVH that may warrant additional risk-assessment or follow-up. AutoChamber quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation.

The AutoChamber Software is an opportunistic AI-powered quantitative imaging tool that provides an estimate of cardiac volume, cardiac chambers volumes and left ventricular (LV) mass from non-contrast chest CT scans as well as contrast-enhanced chest CT scans. In addition to cardiac chambers volume and LV mass, AutoChamber measures and reports cardiothoracic ratio (CTR). AutoChamber Software reads a CT scan (in DICOM format) and extracts scan specific information like acquisition time, pixel size and scanner type. The AutoChamber Software uses an AI trained model to identify cardiac chambers in the field of view and measure the volume of each chamber including left atrium (LA), left ventricle (LV), right atrium (RA), right ventricle (RV), and LV wall (LVW). AutoChamber calculates the volume of each chamber as well as the corresponding total volume of all cardiac chambers and, if the field of view contains the entire width of the thoracic cavity in the axial view, it calculates and reports cardiothoracic ratio (CTR). AutoChamber calculates the volume of each chamber based upon the volume of each pixel multiplied by the number of pixels in the region of interest per slice, multiplied by the number of slices included in each chamber's segmentation. The total volume per chamber is reported in cubic centimeters (CC). In addition to reporting the measured volume in CC per chamber report shows volumes adjusted by body surface area (BSA) and corresponding percentiles using reference data from 5830 people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA). The default cut-off value for further investigations is the 75th percentile but it is optional and subject to provider's judgement. AutoChamber does not provide a numerical individualized risk score/prediction or categorial assessment for whether an individual patient will develop cardiovascular disease over a specified period of their percentile(s). AutoChamber is a post-processing quantitative imaging software that works on existing and new CT scans. The AutoChamber Software is a software module installed by trained personnel only. The AutoChamber Software is executed via a parent software which provides the necessary input and visualizes the output data. The software itself does not offer user controls or access. The user cannot change or edit the segmentation or results of the device. The user must accept or reject the region where the cardiac chamber volume measurement is done. If rejected, the user must retry with a new series of images or conduct an alternate method to measure cardiac chamber volume. The expert's review solely pertains to the region of interest being properly located. Software passes if the healthcare provider sees the cardiac chamber volumes and left ventricular mass highlighted by AutoChamber are correctly placed on the cardiac region based upon expert knowledge. Software fails if the healthcare provider sees the cardiac chamber volumes and left ventricular mass highlighted by AutoChamber are incorrectly placed outside of the cardiac anatomy. Software fails if the healthcare provider sees that the quality of the CT scan is compromised by image artifacts, motion, or excessive noise.

The Automated Bone Mineral Density Software Module (ABMD) is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans ordered for reasons other than BMD measurement. In summary, ABMD is an opportunistic AI-powered tool that enables: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure.

The Automated Bone Mineral Density (ABMD) Software is a software module that estimates bone mineral density in the vertebral bones by averaging Hounsfield Units (HU) in the trabecular area. ABMD Software is a post-processing software that works on existing CT scans. ABMD Software measurements are to be reviewed by radiologists and should be used by healthcare providers in conjunction with clinical evaluation.