FDA Grants De Novo Classification to Imaging Tool for Differentiating Parkinsonian Syndromes
KEY TAKEAWAYS
- FDA De Novo classification was granted to Neuropacs, a diffusion MRI–based software designed to aid in differentiating Parkinsonian syndromes.
Neuropacs analyzes imaging patterns to help distinguish MSA and PSP from Parkinson’s.
The Food and Drug Administration (FDA) has granted De Novo classification to Neuropacs (Neuropacs, Gainesville, FL), a machine learning (ML)–based software application that analyzes diffusion MRI data, intended to assist clinicians in evaluating Parkinsonian syndromes. The designation establishes a new regulatory category—“Parkinsonian syndrome diagnostic aid”—and marks the first device cleared under this classification.
Neuropacs is designed to generate a classification report based on diffusion MRI–derived patterns associated with multiple system atrophy Parkinsonian variant (MSAp) and progressive supranuclear palsy (PSP). The output is intended to provide supplemental information for neuroradiologists and neurologists as part of a broader clinical assessment, particularly in cases where distinguishing these conditions from Parkinson disease (PD) is challenging.
According to a statement from the company, the software operates using standard diffusion MRI sequences commonly acquired on 3T MRI systems and integrates with existing imaging workflows through a cloud-based analysis platform.
The classification was informed by a prospective, multicenter study published in JAMA Neurology and conducted across 21 movement disorder centers within the Parkinson Study Group. Under defined study conditions, the approach demonstrated the ability to differentiate MSAp and PSP from PD, supporting its potential role as an imaging-based adjunct in the evaluation of atypical parkinsonian syndromes.
In a press release, Neuropacs noted that Neuropacs is intended for use alongside clinical judgment rather than as a standalone diagnostic.
The De Novo classification enables future devices of this type to pursue clearance through the 510(k) pathway and supports broader development of imaging-based diagnostic aids in neurodegenerative disease.
Source
Neuropacs. FDA grants de novo classification to neuropacs, a first-in-class AI-baed MRI diagnostic aid for Parkinsonian syndromes. BioSpace. Published April 7, 2026. Accessed April 8, 2026. https://www.biospace.com/press-releases/fda-grants-de-novo-classification-to-neuropacs-a-first-in-class-ai-based-mri-diagnostic-aid-for-parkinsonian-syndromes