FDA clears RadNet AI tool for breast arterial calcification detection on mammography

FDA has cleared RadNet's AI module for detecting breast arterial calcification (BAC) on mammography — a marker of cardiovascular risk. In clinical testing, sensitivity was 90% and specificity 88% across varying breast densities.

• Device clearance (510(k)); the tool automatically flags BAC on mammograms, potentially enabling cardiovascular risk stratification at the time of routine breast imaging.
• Performance reported as 90% sensitivity / 88% specificity across patients with varying breast density; no confidence intervals or comparator benchmark reported in source.
• Clinical and real-world validation details — including reader study design, patient n, and external cohort performance — were not disclosed in the announcement; independent peer-reviewed evidence is not yet available.

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