RadNet, Inc. 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, a more advanced successor to 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.
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.