November 1st, 2025—Imeka, the leading neuroimaging company combining diffusion imaging and AI to map white matter microstructure, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its new and improved flagship software – ANDI 2.0, adding brain volumetric analysis to its capabilities. Brain microstructure now adds macrostructure in a real one-stop-shop for clinicians.