GAINESVILLE, Fla. — Neuropacs™ Corp., an innovator in AI-enabled neurological imaging, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification to neuropacs™, a diffusion MRI–based software application designed to assist clinicians in the evaluation of Parkinsonian syndromes.
neuropacs™ is the first medical device classified by the FDA under the new category of “Parkinsonian syndrome diagnostic aid.” The software analyzes diffusion MRI data to generate a classification report based on degenerative brain patterns of multiple system atrophy Parkinsonian variant (MSAp) and progressive supranuclear palsy (PSP), providing supplemental information to neuroradiologists and neurologists as part of a comprehensive clinical assessment to help in differentiating these diseases from Parkinson’s disease (PD). The software is designed to operate with standard diffusion MRI sequences commonly used across major 3T MRI systems. The technology is built on more than 15 years of research and over 1,000 imaging datasets. In a prospective multicenter study published in JAMA Neurology, the approach demonstrated performance in differentiating MSAp and PSP from PD under defined study conditions. The study, supported by the National Institutes of Health and conducted across 21 movement disorder centers from the Parkinson Study Group, represents a large evaluation of diffusion MRI–based imaging biomarkers in Parkinsonian syndromes.
https://jamanetwork.com/journals/jamaneurology/fullarticle/2831631
Parkinsonian syndromes are often challenging to differentiate clinically, particularly in early stages. neuropacs™ is designed to provide objective, imaging-derived information, along with cloud-based analysis and integration into existing MRI workflows, to support clinical decision-making and research applications. “neuropacs represents an important step forward in the development of imaging-based tools for neurological evaluation,” said Dr. Martin Handfield, President & 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.” The FDA De Novo classification follows Neuropacs’ recently announced $1 million seed round. This funding supports the company’s transition from research to commercialization and expands its clinical and trial‑support capabilities.
About Neuropacs™ Corp.
Neuropacs™ Corp. is an AI-enabled imaging company focused on developing software tools to support the evaluation of neurodegenerative diseases. Automated Imaging Diagnostics LLC, is a wholly owned subsidiary of Neuropacs Corp. Its platform leverages advanced imaging analytics to provide insights for clinical and research applications. https://neuropacs.com/
About neuropacs™
neuropacs™ is a prescription device that analyzes patient-specific data to aid in the diagnosis of Parkinsonian syndromes. The test requires a single, non-invasive, and radiotracer-free diffusion MRI scan, which can be acquired using standard diffusion MRI sequences available on 3 Tesla clinical MRI systems from Siemens, GE Healthcare, and Philips. The brain scan is analyzed using a rigorously validated free-water imaging model and machine learning algorithm. The device provides a classification report based on degenerative brain patterns of multiple system atrophy Parkinsonian variant (MSAp) and progressive supranuclear palsy (PSP) to help neuroradiologists and/or neurologists in differentiating these diseases from Parkinson’s disease (PD). Important Safety Information: The neuropacs™ system is intended to provide supplemental information and is not a standalone diagnostic device. Results should be interpreted in conjunction with clinical evaluation and other diagnostic testing. This device does not rule out other potential causes of Parkinsonism symptoms or signs and is intended to be used after all other potential causes of Parkinsonism symptoms (such as dementia with Lewy bodies, vascular Parkinsonism, drug-induced Parkinsonism, and corticobasal degeneration/syndrome) have been ruled out by trained clinicians on the basis of clinical, neurological, and other laboratory tests. Patient management decisions should not be based solely on neuropacs™ output.
Media Contact
Martin Handfield
President & CEO