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


The artificial intelligence (AI) software Saige-Density™ reportedly provides automated assessment of breast density during mammography exams.

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.

(Editor’s note: For related content, see “Mammography News: FDA Says National Breast Density Notification Rule May Be Published in Late 2022 or Early 2003,” “Can AI Improve the Consistency of Breast Density Assessment by Radiologists?” and “Current Insights on Breast Density, Contrast-Enhanced Mammography and Supplemental Breast Cancer Screening.”)

“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. “We have developed another one of the most advanced AI algorithms to date to support radiologists in their fight to find breast cancer as early as possible.”

DeepHealth previously received FDA 510(k) clearances for the AI mammography triage software Saige-Q and the adjunctive diagnostic mammography software Saige-Dx.


1. RadNet. RadNet’s artificial intelligence subsidiary, DeepHealth, announces FDA clearance of its third AI mammography product. GlobeNewswire. Available at: https://www.globenewswire.com/news-release/2022/12/19/2576071/10985/en/RadNet-s-Artificial-Intelligence-Subsidiary-DeepHealth-Announces-FDA-Clearance-of-its-Third-AI-Mammography-Product.html . Published December 19, 2022. Accessed December 19, 2022.

2. DeepHealth. Saige-Density mammography density assessment software. Available at: https://deep.health/products/saige-density/ . Accessed December 19, 2022.

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