Sam Brusco, Associate Editor07.31.23
Imeka, a neuroimaging company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software.
According to the company, the report ANDI generates offers medical professionals critical reference info on brain white matter as an adjunct to care.
"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," Jean-René Bélanger, CEO at Imeka, told the press. "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."
ANDI automated radiological image processing software extracts white matter bundles that connect specific brain regions and performs microstructure analysis along them. The device processes diffusion-weighted images with modeling, tractography, and fiber bundling to map the white matter’s microstructural properties.
ANDI creates a DICOM-encapsulated PDF report that highlights bundles with the largest deviation from the normative range, as well as detailed analysis of all bundles’ microstructural and macrostructural valves.
"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," said Maxime Descoteaux, co-founder and scientific advisor at Imeka. "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."
According to the company, the report ANDI generates offers medical professionals critical reference info on brain white matter as an adjunct to care.
"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," Jean-René Bélanger, CEO at Imeka, told the press. "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."
ANDI automated radiological image processing software extracts white matter bundles that connect specific brain regions and performs microstructure analysis along them. The device processes diffusion-weighted images with modeling, tractography, and fiber bundling to map the white matter’s microstructural properties.
ANDI creates a DICOM-encapsulated PDF report that highlights bundles with the largest deviation from the normative range, as well as detailed analysis of all bundles’ microstructural and macrostructural valves.
"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," said Maxime Descoteaux, co-founder and scientific advisor at Imeka. "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."