[1] Louis et al. “Equitable impact of an AI-driven breast cancer screening workflow in real-world US-wide deployment.” Nature Health. Nov 2025. [2] FDA 510(k) clearance K251873. Clinical Performance Testing. [3] Pending 510k clearance [4] CE marked for the EU market. Not yet cleared for use in the US. [5] Eriksson et al. “A risk model for digital breast tomosynthesis to predict breast cancer and guide clinical care.” Science Translational Medicine. May 2022. [6] Eriksson et al. “Identification of Women at High Risk of Breast Cancer Who Need Supplemental Screening.” Radiology. Sep 2020. [7] Rapid image processing flags highly suspicion cases in under 5 minutes when integrated with GE HealthCare’s Senographe Pristina system and using 1 GB bandwidth transmission, and under 15 minutes with HOLOGIC [8] Louis et al. “National Deployment of AI-driven Workflow has Equitable Impact in Breast Cancer Screening in Diverse and Increased Risk Populations.” Nature Health. 2025. [9] Louis et al. “Large-scale deployment of a multistage AI-driven workflow increases detection of deadlier breast cancers.” RSNA Chicago. 2025. [10] McCabe et al. “Multistage AI-Driven Workflow Improves General Radiologist Screening Mammography Performance to the Level of Fellowship-Trained Breast Imagers: Real-world Evidence in >500,000 Patients.” RSNA Chicago. 2025. [11] Lee et al. National Performance Benchmarks for Screening Digital Breast Tomosynthesis: Update from the Breast Cancer Surveillance Consortium. Apr 11 2023 https://doi.org/10.1148/radiol.222499

Disclaimers: Breast Suite comprises multiple applications including ProFound Pro, Breast Density, Safeguard Review, Risk Assessment, BAC and DeepHealth Viewer. DeepHealth Viewer is manufactured by eRAD, Inc. and distributed by DeepHealth, Inc. Any claims made about Breast Suite may reference claims associated with its individual components. Not all products and functionalities are commercially available in all countries.