FDA clears prostate AI solution from RadNet subsidiary DeepHealth

The U.S. Food and Drug Administration has cleared a prostate artificial intelligence tool from RadNet subsidiary DeepHealth, the company announced Tuesday. 

Regulatory authorities are green-lighting the new product, which is part of its Prostate Suite of solutions, offering AI assistance for cancer detection and interpretation. RadNet touted the product’s ability to help with all facets of MRI workflows related to the gland, including automatically pinpointing lesions, classifying risk, segmentation and PI-RADS-compliant reporting. 

The company noted that these AI aids are combined into a single platform that’s compatible with 11 fusion biopsy systems, all of which support radiologists’ clinical evaluations.

“One of AI’s most significant contributions in prostate cancer detection is expanding access to prostate screening,” Francesco Giganti, an associate professor of radiology with University College London, said in a statement May 19. “Solutions like DeepHealth Prostate Suite support radiologists throughout the reporting workflow, minimizing delays and helping ensure more men receive timely, accurate care.” 

RadNet claims that real-world deployment of Prostate AI detected 27% more lesions, reduced inter-radiologist segmentation variability by 65% and cut workflow times by 37% for biopsy-recommended cases. 

In addition, RadNet on Tuesday also announced it has earned a CE Mark in Europe for its Brain Health and Brain Age solutions—both of which are already cleared in the U.S. The company additionally earned the same certification for LumbarMR in Europe. RadNet added the solution as part of its $270 million acquisition of French AI firm Gleamer in March. LumbarMR is an AI assistant for lumbar spine MRI exams, supporting radiologists in assessing low back pain.