DeepHealth has received FDA 510(k) clearances for Breast Arterial Calcification Assessment and incorporation of prior exams to its ProFound Pro AI-powered cancer detection application, introducing Mammo Dx1.
The two new functionalities further expand the industry’s most comprehensive Breast Suite2 of solutions – a first-of-its-kind end-to-end suite of modular, interoperable AI-powered applications that address real-world clinical needs across the breast cancer screening and diagnostic pathways.
BAC Assessment analyzes standard 2D (FFDM) and 3D (DBT) mammograms, automatically identifying and flagging breast arterial calcifications within the radiology workflow, with no additional imaging required. In clinical performance testing, DeepHealth’s BAC Assessment demonstrated more than 90% sensitivity and more than 88% specificity across both dense and non-dense breast tissue.3
DeepHealth’s Mammo Dx can now incorporate prior exams into its AI-powered cancer detection workflow, enabling comparison of breast tissue over time to help radiologists identify subtle changes. By bringing prior images into the interpretation process, Mammo Dx supports more informed clinical decision-making, helping radiologists distinguish suspicious findings, reduce false positives, and better determine when additional diagnostic procedures may be recommended.
“With the expanded capabilities of DeepHealth’s Breast Suite, we are providing radiologists with a more complete patient overview, supporting earlier breast cancer detection and more informed follow-up decisions. This reflects the broader impact of end-to-end integrated AI-powered solutions,” said Niccolo Stefani, MD, Business and Product Leader, Population Health & Clinical AI, DeepHealth.
With these clearances, Breast Suite includes BAC Assessment, AI-powered cancer detection, automated density assessment, and risk assessment,4 alongside workflow tools that elevate radiologist performance and enhance operational efficiency—making it an industry-leading suite of solutions. Components of Breast Suite enhance diagnostic accuracy5 and standardization of care6 across more than 10 million mammograms annually.
The two new Breast Suite functionalities are now commercially available in the United States.
References
- The FDA-cleared software previously known as ProFound Pro is now marketed as Mammo Dx including priors. Mammo Dx retains the FDA-cleared capabilities of ProFound Pro and serves as the foundation for ongoing innovation, with additional features and enhancements being introduced over time.
- Breast Suite comprises multiple applications, including Mammo Dx, Breast Density, Safeguard Review, Risk Assessment, BAC Assessment, DeepHealth Viewer, Mammography Insights and Breast Ultrasound. DeepHealth Viewer is manufactured by eRAD, Inc. and distributed by DeepHealth, Inc. Mammography Insights is manufactured by Aquila, Inc. and distributed by DeepHealth, Inc. Any claims made about Breast Suite may reference claims associated with its individual components.
- FDA 510(k) clearance K254131. Clinical Performance Testing.
- Not cleared for use in the U.S. Capability available in Europe.
- Louis, L. et al. “Equitable Impact of an AI-Driven Breast Cancer Screening Workflow in Real World US-wide Deployment.” Nature Health, 2025.
- 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.
