1. MyBreastAI suite is a commercial offering that includes an AI platform optimized for Mammography, ProFound AI for DBT, SecondLook for 2D Mammography and PowerLook® Density Assessment. These three applications are provided by iCAD. MyBreastAI Suite is compatible with the latest versions of iCAD, Inc. as of November 14, 2023.
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.
* Superior diagnostic accuracy demonstrated in a reader study comparing the ROC AUC of GE screening protocol (V-Preview + 3D CC/MLO with 3D in STD mode) to that of 2D FFDM alone. V-Preview is the 2D synthesized image generated by GE Seno Iris mammography software from GE DBT images. FDA PMA P130020 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130020.