The Meals and Drug Administration (FDA) has granted expanded 510(ok) clearance for a number of sclerosis (MS) evaluation with the magnetic resonance imaging (MRI)-based synthetic intelligence (AI) software program Neurophet AQUA.
Beforehand FDA-cleared for evaluation of mind atrophy on MRI, Neurophet AQUA provides superior evaluation of MS and white matter hyperintensities primarily based off of T2-weighted fluid-attention inversion restoration (FLAIR) MRI, in line with Neurophet, the developer of Neurophet AQUA.
The corporate stated key options of the AI-powered software program’s MS evaluation embody:
• exact evaluation of lesion depend, quantity and development by way of enhanced quantification of lesions and structural adjustments;
• volumetric mind area evaluation with out the necessity for 3D T1 photographs; and
• bolstered segmentation of T2-weighted FLAIR photographs at 2D and 3D on 1.5T and 3T MRI platforms.
“MS is a neurological dysfunction that closely depends on MRI for each analysis and illness monitoring, and the McDonald standards, the diagnostic standards for MS, particularly contains MRI affirmation of lesions disseminated in area and time,” stated Jake Junkil Been, the co-CEO of Neurophet. “Neurophet AQUA’s superior MS evaluation expertise considerably enhances effectivity and comfort for healthcare professionals, making it an indispensable instrument in each diagnostic and prognostic levels.”