RadNet, Inc. (NASDAQ: RDNT) announced on Monday that its DeepHeatlh Saige-DXTM mammography and Quantib® Prostate 2.0 MRI artificial intelligence ("AI") algorithms have obtained Food and Drug Administration (FDA) clearance.
Saige-Dx is an artificial intelligence designed to help radiologist detect the presence or absence of breast cancer more effectively. It is a more advanced successor to FDA-approved Saige-Q worklist triage software RedNet said.
The cutting-edge AI algorithm detects worrisome lesions in mammograms and gives a level of suspicion to each finding as well as the entire case.
It aids in the early detection and diagnosis of breast cancer while Quantib® Prostate is an AI-based software solution for MRI prostate reporting that can be accessed immediately from the radiologist's reading station.
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 are among the features included in the solution.
A substantial upgrade to the solution (from release 1.3) has received FDA 510k special clearance, which now incorporates completely automatic prostate zone segmentation (in addition to prostate gland segmentation) and automated initiation of lesion localization on the PI-RADS sector map, decreasing unnecessary recalls.
"All 18 radiologists who participated in our study to support FDA clearance showed better performance while using Saige-Dx, resulting in the biggest increase in performance among all mammography AI systems on the market to date.
"When adopting Saige-Dx, the enhanced performance was reflected in an increase in the percentage of tumors diagnosed as well as a lower false-positive rate "CTO and co-founder of DeepHealth Bill Lotter, Ph.D said.
"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.
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