RadNet receives FDA clearance for cancer detection algorithms

RadNet 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, an advanced successor to its FDA approved Saige-Q worklist triage software, is a cancer detection tool that enables radiologists to detect the presence or absence of breast cancer more effectively with the use of artificial intelligence. DeepHealth’s new AI technology 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. 

Bill Lotter, Ph.D., CTO, and co-founder of DeepHealth, 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.” 

Gregory Sorensen, M.D., CEO, and co-founder of DeepHealth, added: “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.” 

Quantib Prostate 2.0: An AI Powered Solution for prostate MRI reading and reporting 

Quantib Prostate is an AI-based software solution that aims to advance 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 standardised 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 localisation of lesions on the PI-RADS sector map.

Arthur Post Uiterweer, CEO of Quantib, said: “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.

Dr. Howard Berger, president and chief executive officer of RadNet, added: "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.”