FDA clears RadNet's AI-powered breast arterial calcification solution
The U.S. Food and Drug Administration recently cleared a new artificial intelligence-enabled application that targets breast arterial calcification (BAC) on mammograms.
RadNet subsidiary DeepHealth announced the clearance of its Breast Arterial Calcification Assessment on Friday. The module is integrated into its comprehensive suite of Breast Suite solutions.
The module analyzes mammograms for the presence of BAC without requiring additional views or interpretations, automatically flagging areas of concern for radiologists to review. In clinical testing, the module achieved 90% sensitivity and 88% specificity across women with varying levels of breast density.
Additionally, a new functionality that enables DeepHealth’s Mammo Dx to incorporate prior mammograms into its workflow also has been cleared. This will open the door for comparisons of prior imaging that could offer patients more informed and personalized assessments of their breast cancer risk.
“With the expanded capabilities of DeepHealth’s Breast Suite, we are providing radiologists with a more complete patient overview, supporting earlier breast cancer detection and more informed follow-up decisions,” Niccolo Stefani, MD, business and product leader, Population Health & Clinical AI, said in an announcement.
Both clearances are now commercially available in the U.S.
Calls for BAC notifications
While both clearances promise to benefit breast cancer screening assessments, the BAC one is particularly notable amid ongoing talks of the necessity of BAC notifications. Numerous studies have implicated BAC in women’s risk of developing cardiovascular disease and many experts have pushed for mandated inclusion of the finding on mammogram reports, citing opportunities to identify women at risk before the disease progresses. Maryland recently passed legislation that will require radiology providers to inform patients of the presence of BACs on their mammogram. The legislation stipulates that patients should be informed via letter, similar to how the U.S. Food and Drug Administration requires providers to notify women of their breast density.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.