Market for Breast AI in Aiding Screening for Coronary Disease
Alexander McKinney MD, CI-CIIP
Chair, Department of Radiology, University of Miami
Opportunities in Breast AI for Breast Cancer and Coronary Disease Screening
Composed in tandem with Drs. F. Collado-Mesa and J. Net, University of Miami
Over the last 15 years and 7 months (5/25/2008 - 12/22/2023), the FDA has granted clearance to a total of 270 Software as Medical Device (SaMD) products in the field of adult radiology. Of these, 30 (11.1%) SaMD products received FDA cleared in the categories of computer-aided detection (CADe) and computer-aided diagnosis (CADx). These newer CAD tools reportedly perform better, and go beyond, the traditional CAD for mammography first implemented in the 19090s. The anatomic organ with the most FDA-cleared CADe/CADx products is the breast, followed by the lung.
Source: https://aicentral.acrdsi.org/AI-Landscape. Accessed: January 29, 2024.
The most frequent focus of the FDA cleared CADe/CADx products is breast lesion characteristics, followed by pulmonary nodule. Newer foci have been Coronary Artery Disease (CD) screening, based on calcifications noted within breast vasculature on mammography. These can be present in 11-26% of screening mammograms, and deserve further workup on imaging as well as correlation with risk factors. Often, this is composed of a coronary calcium CT for screening.
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SUMMARY:
As AI and other data science products mature and their implementation into clinical practice takes place and expands, including AI tools in the CADt and MIPPS categories, and considering additional AI tools in breast imaging, such as those for breast cancer risk assessment, the AI in breast imaging market is expected to undergo an exponential increment and reach $3.1 billion by year 2031. This estimate could be surpassed as newer AI tools in breast imaging are developed and implemented to assess for diseases outside of the breast, some of which have a larger population health and market impact than breast cancer, such as AI tools for cardiovascular risk assessment by way of breast arterial calcifications.
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