Imeka's brain-mapping AI scores FDA clearance

An artificial-intelligence-powered software tool that builds a detailed map of the brain's white matter to quantify the effects of Alzheimer’s disease, multiple sclerosis and other conditions has been cleared by the FDA.

The Advanced Neuro Diagnostic Imaging (ANDI) imaging software was developed by Canadian startup Imeka. Its AI analyzes diffusion MRI scans of the brain to churn out reports pinpointing areas of the brain that appear to be most affected by neurological conditions.

“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,” CEO Jean-René Bélanger said in a company announcement Monday.

With the FDA 510(k) clearance now secured, Imeka will begin rolling out the ANDI software in the U.S., where it’s expected to be eligible for reimbursement starting next year, thanks to a pair of new coverage codes for “quantitative brain MRI assessment,” according to Bélanger.

The ANDI technology uses modeling, tractography and fiber bundling algorithms first to parse through brain scans to separate white matter into 33 fiber tracts, then to analyze the white matter both as a whole and on a tract-by-tract basis.

Each of the white matter bundles receives its own page of analysis in the software’s report. The analyses include multiple views of each bundle, calculations of the microstructural makeup of the white matter and graphs showing how those microstructural properties differ from those of healthy white matter.

The report also compiles the individual bundle analyses into comprehensive reviews, including one table highlighting all of the areas of a patient’s white matter that fall outside normal ranges.

The software stops short of linking its findings to any specific brain conditions. Instead, according to Imeka, doctors should use the ANDI report as a guide in making their own predictions and diagnoses and planning next steps for a patient’s neurological treatment.

Beyond clinical settings, Imeka has also developed another AI-powered software tool targeting biotech and pharma partners. The Advanced Neuro Imaging Endpoints platform performs white matter microstructure analysis to measure neuroinflammation, axonal degeneration and demyelination, three biomarkers that can then be used by drugmakers to improve clinical trial recruitment and better track the effects of a potential drug to treat Alzheimer’s, Parkinson’s or MS, for example.

The FDA clearance for the ANDI software comes only a few days after Imeka was named the recipient of a chunk of funding from the Canadian government.

The Canada Economic Development for Quebec Regions, or CED, announced last week that it would bestow $250,000 Canadian dollars (about $190,000) upon Imeka. The funding was specifically aimed at supporting the company’s marketing plans for ANDI, and specifically its U.S. expansion, Bélanger said in the announcement.