DeepHealth Secures FDA Clearance for 90%+ Sensitive BAC Assessment and Mammo Dx
RDNT•DeepHealth, RadNet’s AI unit, secured FDA 510(k) clearances for its BAC Assessment tool—demonstrating over 90% sensitivity and 88% specificity in identifying arterial calcifications—and its prior exam integration dubbed Mammo Dx. Both enhancements are now commercially available across RadNet’s U.S. imaging centers, expanding its AI breast imaging portfolio.
1. FDA 510(k) Clearances
DeepHealth, a wholly owned subsidiary of RadNet, received FDA 510(k) clearances for two new Breast Suite functionalities: Breast Arterial Calcification (BAC) Assessment and prior exam integration in ProFound Pro, now branded as Mammo Dx.
2. BAC Assessment Functionality and Performance
BAC Assessment applies to standard 2D (FFDM) and 3D (DBT) mammograms to automatically identify and flag breast arterial calcifications—linked to elevated cardiovascular risk—with clinical testing showing over 90% sensitivity and more than 88% specificity across dense and non-dense breast tissue.
3. Prior Exam Integration with Mammo Dx
Mammo Dx processes past and current mammogram studies to track prior lesions and highlight new ones, enabling radiologists to compare exams over time, reduce false positives and improve cancer detection accuracy.
4. Commercial Availability and Market Impact
Both FDA-cleared tools are now commercially available in the U.S. and will be deployed across RadNet’s network of imaging centers, reinforcing its Breast Suite AI portfolio—which supports diagnostic accuracy on more than 10 million mammograms annually—and driving growth in its Digital Health segment.
