Imeka Brain White Matter Imaging Cleared

FDA has cleared an Imeka 510(k) for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software, which is intended to generate a report for medical professionals on brain white matter as an adjunct to care. The report relies on artificial intelligence diffusion MRI-based white matter imaging to evaluate microstructural properties of white matter, the company says.

Imeka says its ANDI automated radiological image processing software extracts white matter bundles that connect specific regions of the brain and performs microstructure analysis along them. “The device processes diffusion-weighted images using reconstruction algorithms called modeling, tractography, and fiber bundling to map microstructural properties of the white matter,” it explains. “ANDI generates a DICOM-encapsulated PDF report highlighting bundles with the greatest deviation from the normative range and a detailed analysis of all bundles' microstructural and macrostructural values.”