RadNet subsidiary DeepHealth has secured CE marking for its Neuro Suite Brain Health and Brain Age tools and its LumbarMR platform, as well as both U.S. Food and Drug Administration (FDA) 510(k) clearance and CE marking for its Prostate AI tool.
Brain Health automates white-matter hyperintensity detection and segmentation on FLAIR (Fluid-Attenuated Inversion Recovery) imaging, while Brain Age expands segmentation of brain structures including the hippocampus, lobes, and subcortical regions for memory and dementia workups, according to the firm. Both of these are FDA-cleared and are being used at RadNet outpatient imaging sites, DeepHealth said.
LumbarMR, which came to DeepHealth through its acquisition of Gleamer SAS, supports radiologists in assessing low back pain by automatically detecting, characterizing, and reporting on lumbar spine pathology findings. The technology achieves up to 94% sensitivity and reduces reporting time by an average of 17% per exam compared with a resident working without AI assistance, DeepHealth said.
Prostate AI provides automated lesion detection and risk classification, gland segmentation with prostate-specific antigen (PSA) density calculation, and PI-RADS-compliant reporting in a platform compatible with 11 fusion biopsy systems. In real-world deployment, Prostate AI found 27% more lesions, reduced interradiologist segmentation variability by 65%, and reduced workflow time by 37% for biopsy-recommended cases, according to the company. Its Prostate Suite is currently part of TRANSFORM, the U.K.'s largest prostate screening trial, which is expected to analyze more than 100,000 scans.
