DeepHealth, Inc., a subsidiary of RadNet, Inc. (NASDAQ: RDNT), has received two FDA 510(k) clearances for new functionalities within its Breast Suite AI platform, according to a company statement.

The first clearance covers Breast Arterial Calcification (BAC) Assessment, a tool that automatically identifies breast arterial calcifications on standard 2D and 3D screening mammograms without requiring additional imaging. Breast arterial calcifications visible on mammograms have been linked to an elevated risk of cardiovascular events including heart attacks and strokes. In clinical performance testing, the tool demonstrated more than 90% sensitivity and more than 88% specificity in identifying arterial calcifications across both dense and non-dense breast tissue.

The second clearance covers prior exam integration into the company's existing ProFound Pro software, which will now be marketed as Mammo Dx. The tool automatically processes prior and current mammogram studies to track existing lesions and identify new ones, with the stated goal of improving cancer detection rates and reducing unnecessary recalls.

Both functionalities are now commercially available in the United States. BAC Assessment is scheduled to be deployed across RadNet imaging centers nationwide.

DeepHealth states that components of its Breast Suite currently support more than 10 million mammograms performed annually worldwide. The company noted that future cancer risk assessment within the suite is not cleared for use in the United States and remains available only in Europe.

DeepHealth operates as the digital health segment of RadNet, which provides outpatient diagnostic imaging services across 11 U.S. states.