Mammography News: FDA Clears New Functionalities for DeepHealth’s AI-Powered Breast Suite

The Food and Drug Administration (FDA) has cleared the addition of automated breast arterial calcification (BAC) assessment and processing of prior mammograms for the AI-powered Breast Suite software from DeepHealth.

With the capability to analyze full-field digital mammography as well as digital breast tomosynthesis (DBT), DeepHealth said the BAC assessment tool with Breast Suite provides automated detection of BAC, which has been linked to higher risks for stroke and heart attack. Regardless of breast density differences, the BAC assessment tool offers greater than 90 percent sensitivity and greater than 88 percent specificity for BAC detection, according to DeepHealth, a subsidiary of RadNet.

The company added that the Mammo Dx tool with Profound Pro offers automated processing of prior exams that facilitates improved breast cancer detection and reduced recall rates.

“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 (detecting) two of the top causes of death in U.S. women,” noted Niccolo Stefani, MD, the business and product leader for population health and clinical AI at DeepHealth.