cmAngio, a proprietary artificial intelligence (AI)-based software is intended to process Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms to aid qualified interpreting physicians in the identification, visualization, and contextualization of Breast Arterial Calcifications (BAC), an incidental finding. The software functionalities include: - Detection of BAC at both the study and breast level; - Localization of BAC segments by marking detected regions on image thumbnails; - Measurement of Study-level BAC Lengthand View-level BAC Length, representing the extent of detected BAC findings; - Normalization of BAC length and comparison against an age-matched Reference Library to report and display an Age-based BAC Percentile; and - Reporting of Age-based BAC Prevalence based on the same Reference Library. The software is intended to be used by qualified interpreting physicians in parallel with breast cancer screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.
A software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage, image quality assessment) of a trauma or condition (typically orthopaedic, cardiac or pulmonary). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.