DeepHealth Expands Its Breast Suite with Advanced AI Features

DeepHealth has received FDA 510(k) clearance for two significant enhancements to its Breast Suite AI platform: the Breast Arterial Calcification (BAC) Assessment and the ability to incorporate prior exams into its cancer detection capabilities, under the newly branded Mammo Dx1.

These advancements extend the Comprehensive Breast Suite—a leading AI-powered, modular system, offering integrated tools that meet the clinical needs of breast cancer screening and diagnostics.

The BAC Assessment function is designed to automatically detect and highlight breast arterial calcifications using both 2D (FFDM) and 3D (DBT) mammography without needing additional imaging. In clinical evaluations, the BAC Assessment demonstrated greater than 90% sensitivity and over 88% specificity across various breast tissue densities.

Additionally, Mammo Dx now supports the integration of prior mammography exams, allowing clinicians to track breast tissue changes over time, thereby enhancing diagnostic accuracy. This capability aids radiologists in differentiating suspicious findings, reducing false positives, and identifying the need for further diagnostic actions.

Dr Niccolo Stefani, Business and Product Leader at DeepHealth, emphasized the value of these new features: “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.”

The inclusion of these features enhances the Breast Suite by incorporating BAC Assessment with existing AI solutions for cancer detection, automated density assessment, and risk assessment. These tools, alongside workflow optimization technologies, aim to optimize radiologist performance and boost operational efficiency. The Breast Suite now represents one of the most advanced groupings of breast cancer diagnostic tools, processing over 10 million mammograms annually in the United States.

These newly integrated functionalities are now commercially available in the U.S., reinforcing DeepHealth's commitment to innovation in breast cancer diagnostics through AI technology.