Diffusion MRI Software for Parkinsonian Syndromes Gets FDA De Novo Classification

The Food and Drug Administration (FDA) has issued a De Novo classification for neuropacs™, an AI software for 3T diffusion MRI that may enhance differentiation of Parkinson’s disease.¹

Geared toward neuroradiologists and neurologists, the neuropacs software provides a classification report based on assessment of 3T diffusion MRI scans that helps differentiate between Parkinson’s disease and multiple system atrophy Parkinsonian variant (MSAp), progressive supranuclear palsy (PSP), and atypical parkinsonism, according to Neuropacs Corporation, the developer of the software.

“neuropacs represents an important step forward in the development of imaging-based tools for neurological evaluation,” said Martin Handfield, PhD, the president and CEO of Neuropacs. “The FDA’s De Novo classification establishes a new regulatory category for this type of technology and enables broader access to tools that may support clinicians in assessing Parkinsonian syndromes.”

Developed on over 1,000 imaging datasets, the neuropacs software was evaluated in a 2025 prospective multicenter study published in JAMA Neurology.²

Researchers found that the automated imaging differentiation for Parkinsonism (AIDP) analysis provided by the neuropacs software generated a 96 percent or better AUROC for differentiating between Parkinson’s disease, atypical parkinsonism, MASp and PSP.²

“It is possible that the future application of AIDP, in combination with other neuronal α-synuclein biomarkers, may be a useful component of the (Parkinson’s disease) classification and staging system.,” noted lead study author David Vaillancourt, PhD, a distinguished professor and chair of the Department of Applied Physiology and Kinesiology at the University of Florida, and colleagues.

(Editor’s note: For related content, see “FDA Expands Approval of MRI-Guided Ultrasound Treatment for Patients with Parkinson’s Disease,” “SNMMI: Emerging PET Insights on Neuroinflammation with Progressive Apraxia of Speech (PAOS) and Parkinson-Plus Syndrome” and “Can Brain MRI-Based Connectome Mapping Predict the Progression of Parkinson’s Disease?”)

References

1. Neuropacs. FDA grants De Novo classification to neuropacs™, a first-in-class AI-based MRI diagnostic aid for Parkinsonian syndromes. Businesswire. Available at: https://www.businesswire.com/news/home/20260407103902/en/FDA-Grants-De-Novo-Classification-to-neuropacs-a-First-in-Class-AI-Based-MRI-Diagnostic-Aid-for-Parkinsonian-Syndromes . Published April 7, 2026. Accessed April 7, 2026.
2. Vaillancourt DE, Barmpoutis A, Wu SS, et al. Automated imaging differentiation for Parkinsonism. JAMA Neurol. 2025;82(5):495-505.