DeepHealth Receives FDA Clearance, CE Mark for Neuro, Prostate and LumbarMR

May 19, 2026 — DeepHealth has received the CE Mark  for the Brain Health and Brain Age solutions within its Neuro Suite, CE Marking for its LumbarMR solution, and FDA 510(k) clearance and CE Marking for the Prostate AI solution within its Prostate Suite.

“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. These regulatory clearances reflect the evolution and expansion of the DeepHealth portfolio bringing to market new clinical AI solutions that combine and advance capabilities through organic and inorganic innovation. The solutions are now commercially available, enabling expanded access to our leading-edge technologies designed to stage shift disease and enhance diagnostic consistency while driving meaningful gains in operational efficiency,” said Niccolo Stefani, MD, Business and Product Leader, Population Health & Clinical AI, DeepHealth.

Brain Health, Brain Age Get CE Mark

Part of Neuro Suite,¹ Brain Health and Brain Age are AI-powered solutions that automate and standardize neuroimaging analysis, enabling proactive care through normative data comparison and longitudinal tracking.

Brain Health introduces a new, fully automatic algorithm for White Matter Hyperintensity (WMH) detection and segmentation on FLAIR and removing the need for manual intervention.

Brain Age is a next-generation native clinical AI solution expanding the range of segmented brain structures, including hippocampus, lobes and subcortical regions, delivering improved measurement performance for memory and dementia workups. The solution is showing 92% sensitivity in identifying hippocampal atrophy specific to Alzheimer’s disease, even in preclinical stages.²

Already FDA 510(k) cleared, both solutions are being deployed and scaling across outpatient imaging sites of RadNet — a leading national provider of freestanding, fixed-site diagnostic imaging services in the United States.

“We are already seeing significant value in implementing DeepHealth’s Neuro Suite in our daily workflow. The combination of AI-assisted detection and classification with structured reporting is helping us improve efficiency, consistency and diagnostic confidence. I look forward to expanding its use across our practices to further enhance workflow efficiency and high-quality patient care,”said Kevin L. Berger, MD, Diagnostic Radiologist.

CE Mark for LumbarMR³

The LumbarMR solution is one of the newest additions to the DeepHealth clinical AI portfolio, resulting from our acquisition of Gleamer SAS. LumbarMR is an AI solution for lumbar spine MRI that supports radiologists in assessing low back pain by automatically detecting, characterizing and reporting on key lumbar pathology findings. The technology achieves up to 94% sensitivity and delivers an average reduction in reporting time of 17% per exam when compared to a resident working without AI assistance.⁴

FDA 510(k) Clearance, CE Mark for Prostate AI

The Prostate AI solution is part of DeepHealth’s Prostate Suite,⁵ which brings a fully integrated approach to AI-supported prostate cancer detection and interpretation. The solution delivers an end-to-end prostate MRI workflow on a new technology platform, from automated lesion detection and risk classification, intelligent gland segmentation with PSA density calculation and PI-RADS-compliant reporting into a single platform compatible with 11 fusion biopsy systems, all of which support radiologists’ clinical evaluations.

Real-world deployment of Prostate AI detected 27% more lesions,⁶ reduced inter-radiologist segmentation variability by 65%⁶ and reduced workflow time by 37% for biopsy-recommended cases.⁷  

The CE Mark Prostate Suite solution including Prostate AI is currently part of the TRANSFORM program, the U.K.’s largest prostate screening trial in a generation, which is expected to analyze more than 100,000 scans over the course of the study.

“One of AI’s most significant contributions in prostate cancer detection is expanding access to prostate screening. Solutions like DeepHealth Prostate Suite support radiologists throughout the reporting workflow, minimizing delays and helping ensure more men receive timely, accurate care,” said Pr. Francesco Giganti, Associate Professor of Radiology, University College London.

References

1. Neuro Suite comprises multiple applications, including Brain Health, Brain Age and DeepHealth Viewer. DeepHealth Viewer is manufactured by eRAD, Inc. and distributed by DeepHealth.  Any claims made about Neuro Suite may reference claims associated with its individual components. Not all products and functions are available in all markets.

2. Preliminary data from the observational study conducted at ASL Roma 2 on 226 geriatric patients starting from February 2023 to date, to investigate early diagnosis of dementia with the use of neuropsychological tests and AI-powered (DeepHealth ND) MRI automated evaluation of brain volumetry.

3. LumbarMR is manufactured by Gleamer SAS.

4. Data on file. Metrics are based on the results from an internal study conducted by Gleamer SAS.

5. DeepHealth Prostate Suite comprises multiple applications, including Quantib Prostate, DeepHealth Prostate AI and DeepHealth Viewer. Quantib Prostate is manufactured by Quantib BV and distributed by DeepHealth, Inc, in the U.S. DeepHealth Viewer is manufactured by eRAD, Inc. and distributed by DeepHealth, Inc.  Any claims made about Prostate Suite may reference claims associated with its individual components.

6. DeepHealth pivotal study for FDA 510(k) clearance of Prostate AI, 12-reader by 250-case MRMC study and standalone testing on the same 250 exams.  Data on File.

7. Guenzel et al. “Diagnostic Utility of Artificial Intelligence–assisted Transperineal Biopsy Planning in Prostate Cancer Suspected Men: A Prospective Cohort Study.” Euro Urology Focus. Sep 2024.