DeepHealth Expands Clinical AI Portfolio With New FDA and CE Clearances

DeepHealth, a subsidiary of RadNet, has received multiple regulatory clearances across its radiology AI portfolio, expanding its approved products for neuroimaging, lumbar spine MRI analysis, and prostate cancer detection in the U.S. and Europe.

The company announced on 19 May that it received CE Marking for Brain Health, Brain Age, and LumbarMR, along with both FDA 510(k) clearance and CE Marking for its Prostate AI solution. The approvals increase DeepHealth’s portfolio to 27 FDA-cleared and 26 CE-marked technologies across radiology workflows.

The approvals come as imaging providers continue deploying AI systems to manage rising scan volumes, radiologist shortages, and more standardized reporting workflows. Recent healthcare AI deployments have increasingly focused on diagnostic imaging and clinical decision support, including broader adoption of AI-assisted mammography and radiology systems across hospitals and outpatient imaging centers.

DeepHealth said its Brain Health and Brain Age products are part of its Neuro Suite platform, which automates neuroimaging analysis using longitudinal tracking and normative data comparisons. The company said Brain Health includes automated white matter hyperintensity detection and segmentation from FLAIR MRI scans without manual intervention.