Imeka Receives FDA 510(k) Clearance for ANDI Medical Device
SHERBROOKE, QC, July 31, 2023 /PRNewswire/ -- Imeka, the leading neuroimaging company combining diffusion imaging and AI to map white matter microstructure, today 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. 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.
- 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.
- 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," said Jean-René Bélanger, Chief Executive Officer at Imeka.
- The device processes diffusion-weighted images using reconstruction algorithms called modeling, tractography, and fiber bundling to map microstructural properties of the white matter.
- "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."