DeepHealth secures AI clearances for neuro, prostate tools

DeepHealth has received CE marking for Brain Health and Brain Age within its Neuro Suite, CE marking for LumbarMR, and FDA 510(k) clearance and CE marking for Prostate AI.

Brain Health automates white-matter hyperintensity detection and segmentation on FLAIR imaging. Brain Age segments brain structures including the hippocampus, lobes, and subcortical regions for memory and dementia workups, according to the company.

Both neuro tools already have FDA 510(k) clearance and are being deployed across RadNet outpatient imaging sites, DeepHealth said.

LumbarMR came to DeepHealth through its acquisition of Gleamer SAS. The software supports lumbar spine MRI assessment by automatically detecting, characterizing, and reporting lumbar pathology findings.

Gleamer data cited by DeepHealth showed up to 94% sensitivity and an average 17% reduction in reporting time per exam compared with a resident working without AI assistance.

FDA documentation lists DeepHealth ProstateAI as a computer-aided detection and diagnosis software device for prostate MRI exams in men ages 40 years and older. The device analyzes T2-weighted, ADC, and diffusion-weighted MR images.

ProstateAI is intended as a concurrent reading aid for physicians assessing prostate MRI exams. FDA documentation states that the software is not intended to replace physician interpretation or serve as the sole basis for patient management decisions.

DeepHealth said the Prostate Suite includes automated lesion detection and risk classification, gland segmentation with PSA density calculation, and PI-RADS-compliant reporting. The platform is compatible with 11 fusion biopsy systems.

Real-world deployment of Prostate AI detected 27% more lesions, reduced interradiologist segmentation variability by 65%, and reduced workflow time by 37% for biopsy-recommended cases, according to company data.

Prostate Suite is also being used in TRANSFORM, the U.K. prostate cancer screening trial expected to analyze more than 100,000 scans, DeepHealth said.