UF research helps establish new FDA pathway for Parkinson’s diagnostics

2026

by Alisha Katz, APR, MAMC

On Friday, April 3, the U.S. Food and Drug Administration, or FDA, granted De Novo classification to Neuropacs™ Corp. for its diffusion MRI-based software, neuropacs™, which is designed to assist neurologists and neuroradiologists evaluate individuals with early-stage Parkinson’s disease. The approval was made possible by a National Institutes of Health-funded study led by University of Florida researchers.

The study was led by David Vaillancourt, Ph.D., the Orchid Distinguished Professor and chair of the UF Department of Applied Physiology & Kinesiology, as well as a member of the Normal Fixel Institute for Neurological Diseases, in collaboration with Angelos Barmpoutis, Ph.D., a professor in the UF College of the Arts. For more than two and a half years, the UF-led research team evaluated a cohort of 249 patients and a retrospective cohort of 396 patients across 21 Parkinson Study Group sites nationwide and in Canada.

The study examined whether the noninvasive, diffusion MRI-based software — combined with disease-specific machine learning algorithms — could differentiate Parkinson’s disease from related neurodegenerative conditions, including multiple system atrophy Parkinsonian variant and progressive supranuclear palsy, which often present with overlapping symptoms, especially in early stages.

The findings provided clinical evidence to support the safety and effectiveness of the AI-enabled imaging software, representing a significant translational milestone for UF-led neuroscience research. The study was published in the Journal of the Medical Association Neurology in March 2025.

“This FDA authorization provides needed support to improve diagnostic tools for neurological care of people with Parkinson’s and other disorders,” said Vaillancourt, who is also a co-founder and chief scientific officer of Neuropacs™ Corp, an AI-enabled imaging company focused on developing software tools to support the evaluation of neurodegenerative diseases. Barmpoutis is also a co-founder, chief technology officer and chief information security officer at Neuropacs™ Corp.

De Novo classification is an FDA pathway used to approve innovative medical devices that lack a direct predecessor. Since these devices are fundamentally new, they cannot be compared to existing technologies; instead, they must be supported by scientific evidence demonstrating their safety and effectiveness for their intended use.

Because of this, neuropacs™ is the first medical device of its kind to be classified by the FDA under the new category of “Parkinsonian syndrome diagnostic aid,” establishing a new regulatory pathway for diagnostic technologies in movement disorders. The classification underscores the role of academic-industry partnerships and federally funded research in advancing clinical innovation.

“Without the support of NIH and the vision of UF Innovate this would not have been possible,” Vaillancourt said.