DeepHealth Receives FDA Approval for New Breast Imaging Features
DeepHealth, a wholly owned subsidiary of RadNet, announces it has received FDA 510(k) clearances for two new Breast Suite functionalities: Breast Arterial Calcification Assessment, a tool applied to standard screening mammograms that automatically identifies breast arterial calcifications, a potential early indicator of cardiovascular disease; 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. 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.
