ANDI Medical Device by Imeka Successfully Receives FDA 510(k) Clearance
Tuesday, August 01, 2023
Imeka, a prominent neuroimaging company specializing in the fusion of diffusion imaging and AI for white matter microstructure mapping, has announced that the Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance allows medical professionals, including neurologists and radiologists, to access crucial reference information about brain white matter as a supplementary aid in patient care.
In the last two years, several AI-based medical imaging tools have gained FDA clearance for clinical use, underscoring the advancements in this field. Imeka is at the forefront, leading the way in AI-driven white matter imaging based on diffusion MRI, enabling highly detailed evaluations of white matter microstructural properties.
ANDI, Imeka's automated radiological image processing software, focuses on extracting white matter bundles connecting specific brain regions and conducting microstructure analysis along these pathways. It employs sophisticated algorithms like modeling, tractography, and fiber bundling to effectively map the microstructural properties of white matter. The generated DICOM-encapsulated PDF report highlights bundles that significantly deviate from the normative range, presenting a detailed analysis of microstructural and macrostructural values for all identified bundles.