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16 May, 2022

RadNet Artificial Intelligence Subsidiaries, DeepHealth and Quantib, Obtain FDA Clearance for Mammography and Prostate AI Tools

RadNet DeepHealth Quantib Radiology AI FDA Clearance

CAMBRIDGE, Mass. and ROTTERDAM, The Netherlands and LOS ANGELES, May 16, 2022 (GLOBE NEWSWIRE) -- RadNet, Inc., (NASDAQ: RDNT) today announced that it has received FDA clearances for its DeepHealth Saige-DX™ mammography and Quantib® Prostate 2.0 MRI artificial intelligence (“AI”) algorithms.

Saige-DX: AI Mammography Diagnostic Software

Saige-Dx, a more advanced successor to our FDA approved Saige-Q worklist triage software, is a cancer detection tool that enables radiologists to more effectively detect the presence or absence of breast cancer with the use of artificial intelligence. DeepHealth’s powerful new AI technology automatically identifies suspicious lesions in mammograms and assigns a suspicion level to each finding and to the entire case. It helps detect and diagnose breast cancer earlier while reducing unnecessary recalls.

“In our study to support FDA clearance, all 18 radiologists who participated exhibited improved performance when using Saige-Dx, resulting in the largest increase in performance across all mammography AI products on the market to date. The improved performance was reflected in both an increase in the percentage of the cancers detected and a lower false positive rate when using Saige-Dx,” said Bill Lotter, Ph.D., CTO, and co-founder of DeepHealth.

“Saige-Dx is built on our advanced deep-learning algorithms. Our highly accurate AI, as is described in a Nature Medicine article last year, showed the ability to find cancer one to two years earlier than fellowship-trained breast imaging radiologists. The approval of Saige-Dx represents another step forward in advancing cancer care. The feedback from physicians who have worked with our software tools is overwhelmingly positive, making them more accurate and efficient at interpreting mammography images,” said Gregory Sorensen, M.D., CEO, and co-founder of DeepHealth.

Quantib® Prostate 2.0: An AI Powered Solution for Prostate MRI Reading and Reporting

Quantib® Prostate is an AI-based software solution that advances the MRI prostate reporting workflow and is accessible directly from the radiologist’s reading station. The solution comes with a suite of tools to improve reporting quality and speed, including AI-based segmentations and volumetry, PSA density calculation, precise registration and movement correction, one-click segmentation of lesion candidates, PI-RADS scoring support, and standardized reporting to facilitate easy and comprehensive communication of results. FDA 510k special clearance has been given for a major upgrade to the solution (from release 1.3) that now includes fully automatic prostate zone segmentation (in addition to prostate gland segmentation) and automated initiation of localization of lesions on the PI-RADS sector map.

“We are delighted to present this update of Quantib® Prostate, including a selection of new features that our customers requested over the past few months. We seek to continuously improve our software to support radiologists and urologists in the best way possible, and we deliver updated solutions to our customers as quickly as possible,” said Arthur Post Uiterweer, CEO of Quantib.

Dr. Howard Berger, President and Chief Executive Officer of RadNet, said, "We are very proud that two of our subsidiaries, DeepHealth and Quantib, have received FDA clearance for their flagship products. Artificial intelligence will have a transforming impact on radiology and cancer care, and we are committed to delivering those advances to patients and healthcare providers. These recent approvals will help us drive improved patient outcomes while lowering costs. The Biden administration, through its Cancer Moonshot program, is committed to significantly reducing the mortality rates from cancer in the coming decades. We believe that these AI tools will play an important role in the early detection and diagnosis of cancer, resulting in improved survival rates and better patient outcomes.”

About RadNet, Inc.

RadNet, Inc. is the leading national provider of freestanding, fixed-site diagnostic imaging services in the United States based on the number of locations and annual imaging revenue. RadNet has a network of 350 owned and/or operated outpatient imaging centers. RadNet's markets include Arizona, California, Delaware, Florida, Maryland, New Jersey and New York. Together with affiliated radiologists, and inclusive of full-time and per diem employees and technicians, RadNet has a total of approximately 8,300 employees.

About DeepHealth, Inc.

DeepHealth, a wholly owned subsidiary of RadNet, 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. DeepHealth has two FDA-cleared solutions focused on improving the accuracy and efficiency of interpreting mammograms. For more information, visit www.deep.health.

About Quantib

Quantib, a wholly owned subsidiary of RadNet, Inc., provides AI radiology solutions to enable faster and more accurate diagnosis by quickly identifying abnormalities, supporting adequate and timely patient care. Using state-of-the-art artificial intelligence technology, Quantib’s software advances the diagnostic pathway by providing FDA-cleared and CE-marked solutions related to neurodegeneration and prostate cancer. All solutions are deployed through the Quantib AI Node platform, enabling seamless workflow integration and rapid regulatory clearance.

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.

Media Contact – DeepHealth, Inc.:
Bret Baird
Chief Commercial Officer
424-832-1480
bbaird@deep.health

Media Contact – Quantib BV:
Ory Six
Marketing Director
+0031 10 841 1749
o.six@quantib.com

Media Contact – RadNet, Inc.:
Mark Stolper
Executive Vice President and Chief Financial Officer
310-445-2800

16 May, 2022