1. MyBreastAI suite is a commercial offering that includes an AI platform optimized for Mammography, ProFound AI for 2D, ProFound AI for DBT and PowerLook® Density Assessment. These three applications are provided by iCAD.
2. With a service contract.
3. iCAD data on file. FDA filing: K203822. Standalone performance varies by vendor. FDA Cleared and CE Mark Pending. Reading times may vary based on the specific functionality of the viewing application used for interpretation.
4. Reader performance with Profound AI compared to performance without.
iCAD reader study: Conant, E et al. (2019). Improving Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4). Accessed via
https://pubs.rsna.org/doi/10.1148/ryai.2019180096 iCAD labelling and user manual, DTM160 rev C.
5. Sprague B, Conant E, Onega T et al. Variation in Mammographic Breast Density Assessments Among Radiologists in Clinical Practice: A Multicenter Observational Study. Ann Intern Med. 2016; 165(7):457-464. doi:10.7326/M15-2934.
6. iCAD labelling and user manual, DTM135-1, DTM156 -3, DTM184 rev1.
7. iCAD labelling and user manual, DTM103 - Revision C.