Neuropacs™ Corp has received De Novo classification from the U.S. Food and Drug Administration (FDA) for neuropacs™, a diffusion MRI–based diagnostic aid designed to support the evaluation of Parkinsonian syndromes.
The FDA has created a new category, “Parkinsonian syndrome diagnostic aid,” with neuropacs™ as the first authorised device.
The software analyses diffusion MRI data to generate classification reports that identify degenerative brain patterns linked to multiple system atrophy Parkinsonian variant (MSAp) and progressive supranuclear palsy (PSP).
These insights assist clinicians in distinguishing these conditions from Parkinson’s disease (PD) as part of a comprehensive clinical assessment.
Built on more than 15 years of research and over 1,000 imaging datasets, neuropacs™ operates with standard diffusion MRI sequences across major 3T MRI systems.
Its performance has been demonstrated in a prospective multicentre study published in JAMA Neurology, involving 21 movement disorder centres within the Parkinson Study Group.
The classification marks a key regulatory milestone and supports broader clinical adoption. It follows a recent $1 million seed funding round aimed at advancing commercialisation and expanding clinical capabilities.
