CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and LOS ANGELES, May 16, 2022 /PRNewswire/ -- RadNet, Inc., (NASDAQ: RDNT) today announced that it has received FDA clearances for its DeepHeatlh 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.

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