Imeka receives FDA 510(k) clearance for ANDI medical device

Imeka, a leading neuroimaging company specialising in diffusion imaging and AI, has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software. This clearance allows medical professionals, including neurologists and radiologists, to access essential reference information on brain white matter, enhancing patient care.

Jean-René Bélanger, CEO of Imeka, highlighted the significance of AI in diffusion MRI-based white matter imaging, providing detailed evaluations of white matter microstructural properties. The FDA clearance of ANDI will have a substantial impact on brain disease management in the coming years, coinciding with the announcement of two new CPT 3 codes by the AMA for quantitative brain MRI assessment in January 2024.

Imeka's ANDI software automates radiological image processing, extracting white matter bundles that connect specific brain regions and conducting microstructure analysis along these pathways. By using diffusion-weighted images and advanced algorithms, such as modelling, tractography, and fibre bundling, ANDI maps microstructural properties of the white matter. The software generates a detailed DICOM-encapsulated PDF report, highlighting bundles with significant deviations from the normative range and providing a comprehensive analysis of microstructural and macrostructural values for all bundles.

Maxime Descoteaux, Co-founder and Scientific Advisor at Imeka, emphasised that ANDI unlocks critical information in brain white matter tracts, facilitating high-quality and efficient patient care for radiologists, neurologists, and other medical professionals. Imeka's dedication to innovative neuroimaging technologies over the past 12 years plays a pivotal role in advancing the search for cures and treatments for brain diseases.

Click here to read the original news story.