Canada-based neuroimaging firm Imeka has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software.

The ANDI automated radiological image processing software generates white matter bundles that connect specific regions of the brain and executes microstructure analysis simultaneously.

The device analyses diffusion-weighted images utilising reconstruction algorithms such as modelling, tractography, and fibre bundling to map the microstructural characteristics of the white matter.

Imeka has designed ANDI to create a PDF report with DICOM encapsulation.

The report highlights the deviated bundles from the normative range and provides a thorough analysis of the microstructural and macrostructural values of each bundle, the neuroimaging company said.

According to Imeka, the report offers vital reference information on brain white matter as an adjunct to care to medical professionals, including neurologists and radiologists.

Imeka CEO Jean-René Bélanger said: “Imeka is pioneering artificial intelligence (AI) in diffusion Magnetic resonance imaging (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 US – 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.”

The company is engaged in white matter microstructure imaging. It uses advanced MRI processing capabilities and AI to supply insights to the clinical and research communities.

In April last year, Imeka collaborated with GE Healthcare and radiotherapy provider Elekta to offer enhanced radiation therapy and MRI offerings.