UF startup neuropacs™ Corp., an innovator in AI-enabled neurological imaging, announced that the U.S. Food and Drug Administration has granted De Novo classification to neuropacs™, a diffusion MRI–based software application designed to assist clinicians in the evaluation of Parkinsonian syndromes.
neuropacs™ is the first medical device classified by the FDA under the new category of “Parkinsonian syndrome diagnostic aid.” The software analyzes diffusion MRI data to generate a classification report based on degenerative brain patterns of multiple system atrophy Parkinsonian variant (MSAp) and progressive supranuclear palsy (PSP), providing supplemental information to neuroradiologists and neurologists as part of a comprehensive clinical assessment to help in differentiating these diseases from Parkinson’s disease (PD).
Read more about FDA Grants De Novo Classification to Neuropacs™, a First-in-Class AI-Based MRI Diagnostic Aid for Parkinsonian Syndromes.
