Products

Neuropacs Parkinsonian Syndromes
Neuropacs
Clinical Decision Support & Reference
Neuropacs™ is an FDA-cleared AI-based software that analyzes patient-specific diffusion MRI data to help radiologists and neurologists differentiate Parkinson's disease from atypical parkinsonian syndromes like multiple system atrophy Parkinsonian variant (MSAp) and progressive supranuclear palsy (PSP).

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About Neuropacs

Neuropacs is a healthcare AI company that develops an AI-based imaging software suite designed to detect, analyze, and measure changes associated with neurodegenerative diseases. Their platform offers imaging analysis tools and proprietary algorithms that are compatible with existing imaging workflows. This technology enables clinicians and clinical researchers to support diagnosis and evaluate disease progression in both research and clinical settings.

Specifically for physicians, Neuropacs provides automated MRI processing and machine learning software to assist in diagnosing and differentiating common neurodegenerative forms of parkinsonism, including Parkinson’s disease (PD), multiple system atrophy parkinsonian variant (MSA), and progressive supranuclear palsy (PSP). The software utilizes a free-water imaging model to assess for neurodegeneration and a machine learning algorithm to analyze brain scans, providing clinicians with results indicating the likely presence of PD, MSA, or PSP. The test relies on a single, non-invasive diffusion MRI scan without radiotracers, and can be performed on 3 Tesla scanners from major vendors (Siemens, GE Healthcare, and Philips). The FDA has granted De Novo classification to Neuropacs, establishing a new regulatory category for a “Parkinsonian syndrome diagnostic aid,” making it the first device cleared under this classification. This software is intended to provide supplemental information for neuroradiologists and neurologists as part of a broader clinical assessment, particularly when differentiating these conditions from Parkinson’s disease is challenging.

Focus Areas

AI-driven neurological diagnostics neurodegenerative diseases Parkinsonism Parkinson's disease multiple system atrophy parkinsonian variant (MSAp) progressive supranuclear palsy (PSP) MRI analysis machine learning imaging biomarkers

Business Intelligence

Key InvestorsNeuro Investment Group, LLC, HHS
PartnershipsParkinson Study Group (for clinical trials), University of Florida, Mayo Clinic, Vanderbilt University (for research collaborations)
TechnologyCloud-based analysis platform, free-water imaging model, machine learning algorithm, compatible with standard diffusion MRI sequences on 3T MRI systems
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Specialization
Neuropacs specializes in AI-driven neurological diagnostics, particularly for neurodegenerative diseases like Parkinson's disease (PD), Multiple System Atrophy Parkinsonian variant (MSAp), and Progressive Supranuclear Palsy (PSP).
Key Differentiator: FDA De Novo Classification
Neuropacs' software is the first medical device to receive De Novo classification from the FDA under the new category of 'Parkinsonian syndrome diagnostic aid.' This establishes a new regulatory pathway and signifies its unique capabilities in differentiating these complex conditions.
Key Differentiator: High Accuracy
The AI technology has demonstrated high accuracy in clinical studies, achieving 96% accuracy in distinguishing PD from atypical parkinsonism (MSAp and PSP), and 98% accuracy in differentiating MSAp from PSP. These diagnoses were further confirmed in 93.9% to 94% of post-mortem autopsies.
Technology Stack
Neuropacs utilizes a free-water imaging model combined with a machine learning algorithm to analyze standard diffusion MRI sequences from 3 Tesla clinical MRI systems (Siemens, GE Healthcare, and Philips). The platform is cloud-based and powered by AWS.
Imaging Biomarkers
The software analyzes patient-specific diffusion MRI data to generate a classification report highlighting degenerative brain patterns linked to MSAp and PSP, aiding in the differentiation from PD.
Research & Validation
The prescription tool is backed by over 15 years of research and more than 1000 imaging datasets. A prospective multicenter study validating its accuracy was published in JAMA Neurology.
Physician Tip

Neuropacs offers physicians a crucial tool for more accurate and earlier differentiation of Parkinson's disease from atypical parkinsonism (MSAp and PSP), which are often challenging to distinguish clinically, especially in early stages. This can lead to more informed treatment planning and potentially revolutionize the standard of care for diagnosing parkinsonism. The system provides objective, imaging-derived information as a supplemental aid, and results should always be interpreted in conjunction with a comprehensive clinical evaluation and other diagnostic testing. The non-invasive nature of the diffusion MRI scan and its compatibility with standard 3T MRI systems from major vendors (Siemens, GE Healthcare, Philips) ensures ease of integration into existing workflows.

The Neuropacs software is designed for cloud-based analysis and integrates with existing MRI workflows, operating with standard diffusion MRI sequences on 3 Tesla clinical MRI systems from Siemens, GE Healthcare, and Philips. It is powered by AWS, ensuring scalability and high availability.

Products by Neuropacs

1 product in the directory

Neuropacs Parkinsonian Syndromes
Neuropacs
Clinical Decision Support & Reference
Neuropacs™ is an FDA-cleared AI-based software that analyzes patient-specific diffusion MRI data to help radiologists and neurologists differentiate Parkinson's disease from atypical parkinsonian syndromes like multiple system atrophy Parkinsonian variant (MSAp) and progressive supranuclear palsy (PSP).

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Press & Coverage

FirstWord HealthTech
Neuropacs' AI-based software wins FDA nod to differentiate degenerative diseases
Neuropacs' AI-based software for assessing Parkinsonian syndromes using MRI scans received de novo classification from the FDA, making it the first device cleared under a new regulatory category for diagnostic aids. This milestone expands access to imaging-based tools for neurological evaluation.
2026-04
BioSpace
FDA Grants De Novo Classification to Neuropacsu2122, a First-in-Class AI-Based MRI Diagnostic Aid for Parkinsonian Syndromes
Neuropacs Corp. announced that the FDA granted De Novo classification to its diffusion MRI-based software, Neuropacsu2122, designed to assist clinicians in evaluating Parkinsonian syndromes. This marks the first medical device classified under the new 'Parkinsonian syndrome diagnostic aid' category.
2026-04
Pulse 2.0
Neuropacs: Over $1 Million Seed Round Raised To Advance AI MRI Diagnostics For Neurodegenerative Parkinsonism
Neuropacs, a developer of AI-driven neurological diagnostic software, raised over $1 million in seed financing to expand product development and prepare for broader clinical commercialization. The funding will accelerate technology development, key hires, and strategic partnerships.
2026-01
FinSMEs
Neuropacs Closes Over $1M Seed Financing
Gainesville, FL-based Neuropacs, an AI-driven neurological diagnostics company, secured over $1 million in Seed funding from Neuro Investment Group and other backers. The capital will be used to accelerate technology development, recruiting, and strategic partnerships.
2026-01
Business Wire
Neuropacs Announces the Publication of a New Study Comparing the Firstu2011ofu2011Itsu2011Kind FDA De Novou2013Classified Imaging Biomarker for Parkinson's Disease with CSF Alphau2011Synuclein Seed Amplification Assay
Neuropacsu2122 Corp. announced the publication of a study in Annals of Neurology, co-authored by their Co-Founder and Chief Scientific Officer, David Vaillancourt, PhD. The research indicates that a positive alpha-synuclein seed amplification assay (SAA) and the automated imaging differentiation for parkinsonism (AIDP) provide unique information for understanding Parkinson's disease.
2026-06
Medium
Dual-Biomarker Strategy: How Neuropacs is Reshaping Parkinson's Diagnosis
Neuropacs Corp. is transforming Parkinson's disease diagnosis through a dual-biomarker strategy, combining molecular and advanced imaging biomarkers. This approach, supported by a pivotal study in Annals of Neurology and recent FDA De Novo classification, aims to provide a more accurate picture of early-stage Parkinson's.
2026-06
Practical Neurology
FDA Grants De Novo Classification to Imaging Tool for Differentiating Parkinsonian Syndromes
The FDA granted De Novo classification to Neuropacs, a machine learning-based software that analyzes diffusion MRI data to assist in evaluating Parkinsonian syndromes. This establishes a new regulatory category and marks the first device cleared under this classification.
2026-04
UF Innovate
JAMA Neurology Publishes Landmark Study Showing Neuropacsu2122 AI Technology Significantly Enhances the Diagnostic Accuracy of Parkinson's Disease and Atypical Parkinsonism
UF startup Neuropacsu2122 Corp. announced the results of a prospective multicenter study, published in JAMA Neurology, which evaluated its AI technology for diagnosing Parkinson's disease and atypical parkinsonism. The study, funded by the NIH, demonstrated the technology's significant enhancement of diagnostic accuracy.
2025-03

Frequently Asked Questions

Neuropacs' AI-based software is designed to assist clinicians in diagnosing and differentiating common neurodegenerative forms of parkinsonism. This includes Parkinson's disease (PD), multiple system atrophy parkinsonian variant (MSAp), and progressive supranuclear palsy (PSP). The software aims to help radiologists and neurologists differentiate these conditions more accurately, as they can be difficult to distinguish in early stages.
Neuropacs' software works with standard diffusion MRI sequences acquired on 3 Tesla clinical MRI systems from major vendors like Siemens, GE Healthcare, and Philips. The system analyzes patient-specific diffusion MRI data using a free-water imaging model combined with a machine learning algorithm to generate a classification report highlighting degenerative brain patterns.
Neuropacs' AI-based software has received De Novo classification from the FDA, establishing a new regulatory category for 'Parkinsonian syndrome diagnostic aid.' A prospective multicenter study published in JAMA Neurology found the tool was 96% accurate in distinguishing PD from atypical parkinsonism (MSAp and PSP), and 98% accurate in differentiating MSAp from PSP. The diagnoses were further confirmed in 93.9% of postmortem autopsies.
No, the Neuropacs system is intended to provide supplemental information and is not a standalone diagnostic device. Its results should be interpreted in conjunction with a comprehensive clinical evaluation and other diagnostic testing.
Neuropacs is a seed-stage company founded in 2021 that has raised over $1 million in seed funding across two rounds. This funding is intended to accelerate technology development, support key recruiting, and pursue strategic partnerships for broader clinical commercialization.
Neuropacs anticipates its AI technology will revolutionize the current standard of care for diagnosing parkinsonism, leading to more specific diagnoses earlier in the disease process. This improved diagnostic accuracy is expected to have far-reaching impacts on clinical care and the testing of new therapeutics in clinical trials.
Neuropacs is focused on expanding its platform and preparing for broader clinical commercialization and adoption, which includes pursuing strategic partnerships. The company's seed funding will be used in part to accelerate these partnerships.

Investors

Who's funded Neuropacs.

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