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FDA De Novo · Neuropacs · Neurology

neuropacs

Machine-learning MRI aid helps tell MSA-P and PSP apart from Parkinson's.

CompareNeuropacs press release
Granted · De Novo

neuropacs

Neuropacs · Neurology · First FDA-classified Parkinsonian syndrome diagnostic aid

Type
Software or AI
FDA route
De Novo classification
Setting
Cloud-based analysis of scans from 3 Tesla clinical MRI systems
Used by
Neuroradiologists and neurologists; prescription device
Bottom line for your practice
55s read

Neuroradiologists and neurologists can get a supplemental report from one diffusion MRI scan, without a radiotracer, to help differentiate MSAp and PSP from Parkinson's disease. It is not a standalone diagnostic, and patient management decisions should not be based solely on its output.

What it is
Prescription software that analyzes a diffusion MRI brain scan with a free-water imaging model and machine learning algorithm. It produces a classification report based on degenerative brain patterns of multiple system atrophy Parkinsonian variant (MSAp) and progressive supranuclear palsy (PSP).
Indicated for
Patients being evaluated for Parkinsonian syndromes, after all other potential causes of Parkinsonism symptoms have been ruled out by trained clinicians.
What changes
The release does not compare the software with another diagnostic approach. It says Parkinsonian syndromes are often challenging to differentiate clinically, particularly in early stages, and that the software adds imaging-derived information.
Evidence
Performance testingStudy not named in the releaseNo numeric results are reported. The release says that in a prospective multicenter study published in JAMA Neurology, conducted across 21 movement disorder centers, the approach demonstrated performance in differentiating MSAp and PSP from PD under defined study conditions.Accuracy, bench or analytical testing. The source reports no clinical outcome trial, which is common for cleared devices.
Watch for
It provides supplemental information and is not a standalone diagnostic device; results should be interpreted with clinical evaluation and other diagnostic testing. It does not rule out other potential causes of Parkinsonism and is intended for use after those causes have been ruled out.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
De Novo classification. A new type of low-to-moderate-risk device (Class I or II) with no predicate. The FDA reviewed its safety and effectiveness and created a new device type, which later devices can cite as a predicate.

Clinical summary

Cloud software that analyzes standard 3T diffusion MRI, with no radiotracer, to help distinguish multiple system atrophy (parkinsonian variant) and progressive supranuclear palsy from Parkinson's disease. The De Novo grant created a new device category; the company cites a prospective, NIH-supported study at 21 Parkinson Study Group centers but reports no accuracy figures in its release. It is an adjunct for use after other causes of parkinsonism have been ruled out, and management should not rest on its output alone.

From the source 12

Neuropacs press release

The Neuropacs press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. today announced that the U.S. Food and Drug Administration has granted De Novo classification to neuropacs™, a diffusion MRI–based software application designed to assist clinicians in the evaluation of Parkinsonian syndromes.

    Backs · Pathway De Novo

  2. neuropacs™ is the first medical device classified by the FDA under the new category of “Parkinsonian syndrome diagnostic aid.”

    Backs · 'First' claim

  3. In a prospective multicenter study published in JAMA Neurology, the approach demonstrated performance in differentiating MSAp and PSP from PD under defined study conditions.

    Backs · Prospective multicenter study in JAMA Neurology; no numeric results

View all 12 lines

  1. 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.

    Backs · 21 movement disorder centers

  2. 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.

    Backs · Single radiotracer-free diffusion MRI scan on 3 Tesla systems

  3. The brain scan is analyzed using a rigorously validated free-water imaging model and machine learning algorithm.

    Backs · Free-water imaging model and machine learning algorithm

  4. neuropacs™ is a prescription device that analyzes patient-specific data to aid in the diagnosis of Parkinsonian syndromes.

    Backs · Prescription device

  5. 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).

    Backs · Operator: neuroradiologists and/or neurologists

  6. The neuropacs™ system is intended to provide supplemental information and is not a standalone diagnostic device.

    Backs · Not standalone

  7. 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.

    Backs · Use after other causes ruled out

  8. Patient management decisions should not be based solely on neuropacs™ output.

    Backs · Management not based solely on output

  9. 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.

    Backs · Cloud-based analysis; hard to differentiate clinically

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