DeepHealth has received CE Marking 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.
CE Mark for Brain Health and Brain Age
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Part of Neuro Suite, 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.
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.
