Imeka, the neuroimaging company combining diffusion imaging and AI to map white matter microstructure, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software.
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FDA approved
The report generated by ANDI provides medical professionals, including but not limited to neurologists and radiologists, with important reference information on brain white matter as an adjunct to care.
Jean-René Bélanger, chief executive officer at Imeka, said: “Many medical imaging tools involving AI have been cleared for use in the clinic in the past two years, which shows the strength and progression of the field. 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. We are pleased to announce FDA 510(k) clearance of ANDI, our quantitative imaging software, and make the technology available to healthcare providers across the U.S. – which is going to have a major impact in brain disease management in the coming years. This also comes at a very crucial time with the announcement of the addition of two new CPT 3 codes by the AMA for quantitative brain MRI assessment, which we expect our clients to be able to get reimbursement from, starting in January 2024.”
Imeka’s 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 modelling, tractography, and fibre bundling to map microstructural properties of the white matter. 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.
Maxime Descoteaux, co-founder and scientific advisor at Imeka, added: “Imeka has spent the past 12 years developing novel neuroimaging technologies that play an influential role in the search for and development of cures for brain diseases. 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.”
