DeepHealth Gets FDA Nod for AI Mammography Software That Assesses Breast Density

In light of a pending national standard requiring breast density notification in mammography reports, an emerging artificial intelligence (AI) tool may help reduce subjectivity and variability in breast density assessments. The Food and Drug Administration (FDA) has granted 510(k) clearance for Saige-Density (DeepHealth/RadNet), an adjunctive AI software that provides automated categorization of breast density based on the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) classification. DeepHealth said a retrospective, multicenter study showed a 91.5 percent alignment between Saige-Density assessment and consensus assessment of breast density by five specialists in breast imaging. The Saige-Density AI algorithm was trained on a racially diverse database of over 166,000 images from 30,000 mammography exams across the United States, according to DeepHealth. "Achieving FDA clearance for another important tool in the breast cancer screening process in such a short time frame highlights our aggressive commitment to bringing state-of-the art AI innovation to the breast screening mammography market," noted Gregory Sorenson, M.D., the CEO and co-founder of DeepHealth.