FDA grants 510(k) clearance for software to image the brain’s white matter

The FDA has granted 510(k) clearance to a Canadian neuroimaging company for its quantitative imaging software, which assists neurologists and radiologists dealing with brain white matter issues for adjunctive care.

According to a press release from Imeka, the Advanced Neuro Diagnostic Imaging (ANDI) software extracts white matter bundles that connect specific regions of the brain and analyzes their microstructure. The artificial intelligence-assisted device processes diffusion-weighted images via modeling, tractography and fiber bundling to map microstructural properties of the white matter.

ANDI then generates a Digital Imaging Communications in Medicine (DICOM) report, which focuses on the bundles with the greatest deviation from the normative range, and offers a detailed analysis of all bundles’ microstructural and macrostructural values, the company said.

“We are pleased to announce FDA 510(k) clearance of ANDI, our quantitative imaging software, and make the technology available to health care providers across the U.S.,” Imeka CEO Jean-René Bélanger said in the release. “This also comes at a very crucial time with the announcement of the addition of two new CPT III 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."