RadNet Receives FDA Clearance for Cancer Detection Algorithms

RadNet has received FDA clearances for its DeepHealth Saige-DX mammography and artificial intelligence (AI) Quantib Prostate 2.0 MRI 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 allows radiologists to more effectively detect the presence or absence of breast cancer through to the use of artificial intelligence. DeepHealth’s new AI technology identifies suspicious lesions in mammograms and assigns a level of suspicion to each finding and the entire case. It helps detect and diagnose breast cancer earlier while reducing unnecessary callbacks.

Bill Lotter, Ph.D., CTO and co-founder of DeepHealth, said, “In our study to support FDA clearance, all 18 participating radiologists showed improved performance when using Saige -Dx, which has resulted in the greatest increase in performance across any mammography AI product on the market today. The improved performance resulted in both an increase in the percentage of cancers detected and a lower false positive rate when using Saige-Dx.

Gregory Sorensen, MD, CEO and Co-Founder of DeepHealth, added, “Saige-Dx is based on our advanced deep learning algorithms. Our highly accurate AI, as described in a Nature Medicine article last year, has shown the ability to detect cancer one to two years earlier than fellow-trained breast imaging radiologists. The approval of Saige-Dx represents another step forward in the advancement of cancer care. Feedback from physicians who have worked with our software tools is overwhelmingly positive, making them more accurate and efficient in 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 prostate MRI 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 volumetrics, PSA density calculation, accurate registration and motion correction, one-click segmentation of lesion candidates, support for PI-RADS scoring and standardized reporting. to facilitate a simple and complete communication of the results. FDA 510k Special Clearance has been granted for a major solution upgrade (from version 1.3) which now includes fully automatic prostate area segmentation (in addition to prostate segmentation) and automated initiation of lesion localization on the PI-RADS sector map.

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

Dr. Howard Berger, President and CEO of RadNet, added, “We are very proud that two of our subsidiaries, DeepHealth and Quantib, have received FDA clearance for their lead products. Artificial intelligence will have a transformative impact on radiology and cancer. care, and we are committed to delivering these advances to patients and healthcare providers. These recent approvals will help us improve patient outcomes while reducing costs. The Biden administration, through its Cancer Moonshot program, is committed to dramatically reducing cancer death rates. We believe these AI tools will play an important role in the early detection and diagnosis of cancer, which which will result in improved survival rates and better patient outcomes.

Sharon D. Cole