Imaging AI targeting Parkinson's earns FDA's De Novo classification
A new MRI software designed to improve the diagnosis of Parkinsonian syndromes has earned De Novo classification from the U.S. Food and Drug Administration.
The product is developed by Neuropacs Corp., an imaging AI company that makes tools to evaluate neurodegenerative disease. Its Neuropacs software helps radiologists and other clinicians differentiate between Parkinson’s, atypical parkinsonism, and other clinical concerns. Such diagnoses are challenging for physicians but crucial to treatment planning, experts note.
The software quantifies MRI data to provide a classification based on patterns of multiple system atrophy Parkinsonian variant and progressive supranuclear palsy. When combined with clinical assessments, the tool can provide a clearer picture of what is causing patients’ symptoms, enabling more informed treatment planning decisions.
“Neuropacs represents an important step forward in the development of imaging-based tools for neurological evaluation,” Martin Handfield, PhD, president and CEO of Neuropacs, said in a statement. “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.”
This represents the first medical device to be classified under the FDA’s new category of “Parkinsonian syndrome diagnostic aid.” The AI software was trained and validated on more than 1,000 imaging datasets; in a clinical study, it achieved 96% area under the receiver operating characteristic curve for differentiating Parkinsonian syndromes. It can be used across major 3T systems (Siemens Healthineers, GE HealthCare, and Philips) and is easily integrated into existing MRI workflows.
Its De Novo classification could expand access to this AI assistant. The FDA designates low to moderate risk devices to this pathway if they do not qualify for a 510(k) but also do not require premarket approval.
Learn more about the software here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.