Imeka logoImeka announced that the FDA granted 510(k) clearance for its advanced neuro diagnostic imaging (ANDI) quantitative imaging software.

Canda-based Imeka, which has previously partnered with GE HealthCare designed ANDI to generate reports for medical professionals. These reports offer important reference information on brain white matter as an adjunct to care.

The ANDI automated radiological image processing software extracts white matter bundles connecting regions of the brain. It then performs microstructure analysis, processing diffusion-weighted images. ANDI processes the images through reconstruction algorithms called modeling, tractography and fiber bundling. This maps microstructural properties of the white matter.

Imeka said in a news release that ANDI generates a DICOM-encapsulated PDF report. It highlights bundles with the greatest deviation from the normative range and a detailed analysis of microstructural and microstructural values.

Jean-René Bélanger, Imeka CEO, said FDA clearance comes “at a very crucial time” with brain MRI reimbursement changes coming next year. The AMA added two new CPT 3 codes for quantitative brain MRI assessment. Bélanger expects clients to receive reimbursement through those codes beginning in January 2024.

“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 Bélanger. “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.”