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.

Brain Age expands analysis across hippocampal, lobar, and subcortical brain regions for dementia and memory evaluations. According to the company, the system demonstrated 92% sensitivity in identifying hippocampal atrophy associated with Alzheimer’s disease, including preclinical stages.

“At DeepHealth, we believe we are delivering the world’s most comprehensive portfolio of native clinical AI solutions and services in radiology, with the aim of creating a new standard of AI-powered care,” Niccolo Stefani, MD, Business and Product Leader, Population Health and Clinical AI at DeepHealth, said in the announcement.

The Neuro Suite products are already FDA-cleared and are being deployed across outpatient imaging centers operated by RadNet in the U.S.

Lumbar MRI and Prostate AI Expansion

DeepHealth also received CE Marking for LumbarMR, an AI system designed to support lumbar spine MRI interpretation and low back pain assessments. The product entered the DeepHealth portfolio through RadNet’s acquisition of French radiology AI company Gleamer SAS earlier this year.

According to DeepHealth, LumbarMR automatically detects and characterizes lumbar pathology findings and reduces reporting time by 17% per exam compared to residents working without AI assistance. The company said the system achieves up to 94% sensitivity.

The company also secured FDA 510(k) clearance and CE Marking for Prostate AI, part of its broader Prostate Suite platform. DeepHealth said the system combines lesion detection, risk classification, gland segmentation, PSA density calculation, and PI-RADS-compliant reporting into a single workflow platform compatible with 11 fusion biopsy systems.

The company said real-world deployment of Prostate AI detected 27% more lesions, reduced inter-radiologist segmentation variability by 65%, and lowered workflow time by 37% for biopsy-recommended cases.

The CE-marked Prostate Suite is also being used in the U.K.’s TRANSFORM prostate screening trial, which is expected to analyze more than 100,000 scans during the study period, according to Prostate Cancer UK.

“One of AI’s most significant contributions in prostate cancer detection is expanding access to prostate screening,” Francesco Giganti, Associate Professor of Radiology at University College London, said in the company announcement.

The regulatory clearances also expand DeepHealth’s push into integrated radiology AI platforms following its broader portfolio expansion showcased during ECR 2026 and growing adoption of FDA-cleared clinical imaging AI systems across healthcare providers.