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neuropacs

Neuropacs · FDA De Novo

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

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. Authorization created a new device category and rested on a prospective, NIH-supported study at 21 Parkinson Study Group centers. It is an adjunct only: it does not exclude other causes of parkinsonism, and management should not rest on its output alone.

Read the primary source: Neuropacs press release

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