DeepHealth Nets FDA Clearance of its Third AI Mammography Product

RadNet, Inc. announced that its subsidiary DeepHealth, Inc., a leading developer of artificial intelligence (AI) for mammography interpretation, has received FDA clearance of its mammography density assessment software, Saige-Density.

Saige-Density is a breast density assessment tool that automatically generates an ACR BI-RADS breast density category, assisting radiologists in making accurate and consistent determinations using AI. The tool helps to reduce the subjectivity inherent in visual analysis.

Almost half of the United States population of women over the age of 40 are considered to have dense breast tissue. Dense breast tissue makes it more di􀀂cult for radiologists to detect cancer in a screening mammogram, requiring more attention by the radiologist and potentially indicating additional diagnostic tests. Additionally, women’s risk of developing breast cancer increases as the level of density increases. As a result, 38 US states currently have laws that require screening service providers to alert women about the significance of breast density and, in many cases, provide breast density scores, and the FDA will soon require that all women nationwide be provided density information. Saige-Density assists the radiologist in determining this density score with improved accuracy and consistency, which can play an important role in the earlier identification of cancer.

This approval marks the third DeepHealth AI product to receive FDA clearance in less than two years. Saige-Density joins the growing family of dynamic DeepHealth AI tools including Saige-Q (a productivity worklist, triage, and prioritization tool) and Saige-Dx (a diagnostic breast cancer screening software that recently showed in a pivotal study to improve performance for all radiologists who used it).

“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,” stated Gregory Sorensen, MD, 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. Our team continues to build on that foundation, and we intend to further innovate and commercialize products that leverage the tremendous advantages of being part of RadNet.”