FDA Grants 510(k) Clearance to New AI-Based White Matter Imaging Technology

The Food and Drug Administration (FDA) has granted 510(k) clearance to a new software tool called Advanced Neuro Diagnostic Imaging (ANDI) (Imeka, Sherbrooke, Canada), which analyzes diffusion-weighted imaging (DWI) using artificial intelligence (AI) to map white matter in the brain. This technology also provides details about the microstructural makeup of the white matter and creates graphs showing differences between microstructural changes and normal values.

ANDI processes data obtained through DWI using reconstruction algorithms, identifying the white matter bundles that connect different brain regions and analyzing their microstructural and macrostructural values. The software provides its analyses to physicians as a PDF file that conforms to Digital Imaging and Communication in Medicine (DICOM) standards for imaging. Imeka anticipates that ANDI will become available to health care providers throughout the United States and will significantly improve disease management in clinical neurology due to the enhanced analysis of the images it provides.

“With ANDI, we're unlocking important information in brain white matter tracts that can assist radiologists, neurologists, and other medical professionals in providing high-quality, efficient patient care,” said Maxime Descoteaux, Cofounder and Scientific Advisor at Imeka.