DeepHealth has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two new functionalities within its Breast Suite AI platform.
These include the Breast Arterial Calcification (BAC) Assessment tool and Mammo Dx, an updated version of its ProFound Pro tool incorporating prior exam integration.
BAC Assessment automatically identifies BACs on standard 2D and 3D mammograms without requiring additional imaging, according to the company. In clinical performance testing, the tool demonstrated more than 90% sensitivity and more than 88% specificity for identifying arterial calcifications across both dense and non-dense breast tissue, DeepHealth said.
BACs that are visible on mammograms have been linked to elevated risk of future cardiovascular events including heart attacks and strokes. BAC Assessment will be deployed across RadNet imaging centers in the U.S.
Mammo Dx enables automatic processing of prior and current mammography studies to track prior lesions and distinguish new findings, with the goal of improving cancer detection rates and reducing recalls, the company said. Both functionalities are now commercially available in the U.S.
