FDA Clears Updated AI Software for MRI Neuroimaging

The Food and Drug Administration (FDA) has granted 510(k) clearance for the updated NeuroQuant® 5.0 software, which offers enhanced magnetic resonance imaging (MRI)-based artificial intelligence (AI) capabilities for assessing patients being treated for Alzheimer’s disease and other neurological conditions.

NeuroQuant 5.0 features advanced segmentation and quantification for amyloid-related imaging abnormalities (ARIA) detected on brain MRI scans of patients being treated with anti-amyloid therapies for Alzheimer’s disease, according to Cortechs.ai, the manufacturer of the software.

The company adds that the deep learning capabilities within NeuroQuant 5.0 facilitate improved visualization of lesions associated with traumatic brain injury (TBI), ARIA-E, ARIA-H and cerebral amyloid angiopathy. Another benefit of the NeuroQuant 5.0 software involves the integration of susceptibility-sensitive MRI sequences that enhance detection of smaller brain lesions, according to Cortechs.ai.

"With this release, we are transforming the way radiologists and neurologists approach neurological evaluations, helping to ensure more accurate and timely diagnoses for patients,” noted Kyle Frye, the chief executive officer at Cortechs.ai.