Neurophet Secures FDA 510(k) Clearance for Multiple Sclerosis Analysis with ‘Neurophet AQUA’

November 25, 2024
4:38 pm

SEOUL, South Korea, Nov. 25, 2024 /PRNewswire/ -- Neurophet, an artificial intelligence (AI) solution company for brain disease, announced on the 25th that its brain MRI analysis software "Neurophet AQUA", has obtained 510(k) clearance from U.S. Food and Drug Administration (FDA) for its newly integrated multiple sclerosis (MS) analysis functionality.

The initial clearance, secured in May last year, authorized brain atrophy analysis using T1-weighted images derived from MRI scans, specifically targeting neurodegeneration conditions. The latest clearance extends the software’s capabilities, incorporating advanced analysis of MS and white matter hyperintensities (WMH) using T2-FLAIR images.

Neurophet AQUA analyzes MRI (magnetic resonance images) with AI technology to analyze brain atrophy and WMH observed in neurodegenerative diseases such as Alzheimer’s disease. It provides rapid segmentation and analysis of brain images across all demographics, delivering results within just five minutes.

The software’s MS analysis technology quantifies lesions and structural changes, enabling precise measurement of lesion count, volume, and progression. Notably, it delivers robust segmentation across both 2D and 3D imaging methods of T2-FLAIR MRI at 1.5T and 3.0T, while also enabling volumetric analysis of brain regions without requiring 3D T1 imaging.

Neurophet Secures FDA 510(k) Clearance for Multiple Sclerosis Analysis with ‘Neurophet AQUA’

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