FDA Clears Adjunctive AI Mapping of White Matter on Diffusion MRI

The Food and Drug Administration (FDA) has granted 510(k) clearance for Advanced Neuro Diagnostic Imaging (ANDI, Imeka), an artificial intelligence (AI)-enabled neuroimaging software that provides mapping of white matter microstructure on diffusion magnetic resonance imaging (MRI).

Employing a combination of modelling reconstruction algorithms, fiber bundling and tractography, the ANDI software platform assesses the microstructure of connecting white matter bundles through automated processing of diffusion-weighted MRI, according to Imeka.

The company said the ANDI software provides detailed analysis of the micro- and macrostructural values of white matter bundles and produces a subsequent DICOM-encapsulated PDF report noting white matter bundles that may have significant deviation from normative values.

“Imeka is pioneering AI in diffusion MRI-based white matter imaging to evaluate microstructural properties of white matter in greater detail than any other techniques,” noted Jean-Rene Belanger, the chief executive officer of Imeka.

Imeka added that recently announced CPT 3 codes from the American Medical Association (AMA) are geared toward quantitative brain MRI assessment and should facilitate reimbursement for use of the ANDI software.