• Breast Arterial Calcification (BAC) Assessment, a tool applied to standard screening mammograms that automatically identifies breast arterial calcifications, a potential early indicator of cardiovascular disease;2
  • Prior exam integration into ProFound Pro, which enables automatic processing of prior and current studies to track prior lesions and distinguish new lesions, with the goal of improving cancer detection rates and reducing recalls. ProFound Pro with prior exam integration will be brought to market as Mammo Dx.3

The two additions reinforce Breast Suite as the industry’s most comprehensive end-to-end breast imaging AI suite—a modular, interoperable portfolio of applications addressing real-world clinical needs across breast cancer screening and diagnostic pathways. Both newly FDA cleared functionalities are now commercially available in the United States.

"Our strategy has always centered around using AI to find disease early. BAC Assessment and Mammo Dx are proof points of that strategy: one adds a cardiovascular evaluation to a routine breast cancer screening mammogram and the other incorporates changes from past mammogram exams into current mammograms to improve cancer detection. Together, they transform Breast Suite into a fully integrated suite of solutions that give radiologists a more complete patient overview and added clinical confidence in two of the top causes of death in U.S. women," said Niccolo Stefani, MD, Business and Product Leader, Population Health & Clinical AI, DeepHealth.

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 beyond the mammogram. BACs visible on mammograms have been linked to an elevated risk of future cardiovascular events, including heart attacks and strokes.2 In clinical performance testing, DeepHealth’s BAC Assessment demonstrated more than 90% sensitivity and more than 88% specificity in identifying arterial calcifications across both dense and non-dense breast tissue.4 BAC Assessment is now commercially available and will be deployed across RadNet imaging centers in the U.S., providing additional real-world validation of its capability.

With the addition of prior exams, Mammo Dx enables the comparison of breast tissue over time amongst prior and current exams and helps radiologists identify subtle changes with lesions that may be undetected on a single-exam read. Mammo Dx brings prior findings into the interpretation process, supporting more informed clinical decision-making with the ultimate goal of helping reduce false positives and better determining when additional diagnostic procedures may be warranted.

With these clearances, DeepHealth’s Breast Suite now includes BAC Assessment, Mammo Dx for cancer detection and diagnosis, automated breast density assessment and future cancer risk assessment,5 alongside workflow tools that elevate radiologist performance and enhance operational efficiency. Today, components of Breast Suite support diagnostic accuracy6 and standardization of care7 across more than 10 million mammograms performed annually across the world.