RadNet’s Artificial Intelligence Subsidiary, DeepHealth, Announces FDA Clearance of its Third AI Mammography Product

Rhea-AI Summary

RadNet announced that its subsidiary, DeepHealth, received FDA clearance for its AI mammography density assessment tool, Saige-Density™. This innovative software automates breast density categorization, aiding radiologists in detecting cancer more effectively. With nearly half of women over 40 classified as having dense breast tissue, this tool is crucial for accurate evaluations, especially as many states mandate breast density notifications. Saige-Density™ is the third AI product from DeepHealth to gain FDA approval, showcasing the company's commitment to enhancing mammography through advanced technology.

Positive

• FDA clearance of Saige-Density™, enhancing mammography accuracy.
• Release of third AI product in two years indicates strong innovation pipeline.
• Addresses regulatory requirements across multiple states, potentially increasing demand.

Negative

• None.

CAMBRIDGE, Mass. and LOS ANGELES, Dec. 19, 2022 (GLOBE NEWSWIRE) -- RadNet, Inc. (NASDAQ: RDNT), today 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 difficult 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 U.S. 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 market-leading 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, M.D., 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.”

About RadNet, Inc.

RadNet, Inc., is the leading national provider of freestanding, fixed-site diagnostic imaging services and related information technology solutions (including artificial intelligence) in the United States based on the number of locations and annual imaging revenue. RadNet has a network of 349 owned and/or operated outpatient imaging centers. RadNet's markets include California, Maryland, Delaware, New Jersey, New York, Florida, and Arizona. Together with affiliated radiologists, including full-time and per diem employees and technologists, RadNet has approximately 9,000 employees. For more information, visit www.radnet.com.

About DeepHealth, Inc.

DeepHealth, Inc., uses machine learning to distill lifetimes of insights from medical experts into software to assist physicians. DeepHealth's mission is to enable the best care by providing products that clinicians and patients can trust through rigorous science and clinical integration. For more information, visit www.deep.health.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are expressions of our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, and anticipated future conditions, events and trends. Forward-looking statements can generally be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods.

Forward-looking statements are neither historical facts nor assurances of future performance. Because forward-looking statements relate to the future, they are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not place undue reliance on any of these forward-looking statements.

CONTACT:

RadNet, Inc.
Mark Stolper, Executive Vice President and Chief Financial Officer
310-445-2928

DeepHealth, Inc.
Bret Baird
Chief Commercial Officer
480-236-6969

FAQ

What is Saige-Density™ and its significance for RadNet (RDNT)?

Saige-Density™ is an FDA-cleared AI tool that assesses breast density, aiding radiologists in detecting cancer more accurately, particularly in women over 40.

How does Saige-Density™ impact breast cancer screening in the U.S.?

It helps standardize breast density categorization, crucial for compliance with new FDA requirements and state laws mandating breast density notifications.

What is the role of DeepHealth in RadNet's growth?

DeepHealth is a subsidiary focused on AI innovations in mammography, contributing to RadNet's strategy of leveraging technology for improved diagnostic services.

What other AI products has DeepHealth launched?

In addition to Saige-Density™, DeepHealth also launched Saige-Q™ and Saige-Dx™, enhancing workflow and diagnostic accuracy in breast cancer screening.

When was Saige-Density™ approved by the FDA?

Saige-Density™ received FDA clearance on December 19, 2022.