GE HealthCare wins clearance for Alzheimer’s detection tool

Alzheimer’s disease is the seventh leading cause of death in the US, according to the National Institute on Aging. In 2023, about 6.7 million people aged 65 and older had Alzheimer’s, and projections from the Alzheimer’s Association show that number could rise to 13.8 million by 2060.

Now, GE HealthCare has a new tool to aid clinicians in dementia detection.

The Chicago-based medical device company announced on September 17 that it received FDA clearance to use its brain-scanning software MIMneuro, which is already in use at 1,000+ facilities around the world, to detect Alzheimer’s in clinical settings. The new 510(k) clearance allows an already approved device to be used for another purpose.

Acquisition payoff. Back in April, GE HealthCare acquired MIM Software, the company that created MIMneuro, an imaging software that conducts a positron emission tomography, or PET, scan that uses the Centiloid scale, which measures the density of amyloid plaque in patient's brains. Beta-amyloid proteins in the brain are often a sign of Alzheimer’s, as they are connected to cell death and loss of tissue, according to the Alzheimer’s Association.

MIMneuro has been on the market since 2006 for research purposes, but it was used only in studies on neurological conditions and disorders, according to MIM Software.

New pharmaceutical treatments that fight amyloid proteins to delay cognitive decline in patients have also emerged, like Eli Lilly’s Kisunla and Eisai and Biogen’s Leqembi, and GE HealthCare’s technology is designed to help clinicians make diagnoses by scanning the brain with a Centiloid scale-based analysis.

“Alzheimer’s is a far-reaching disease that has been a challenge for our society, patients, caregivers, and healthcare systems for decades,” Andrew Nelson, CEO of MIM Software at GE HealthCare, said in the release. “By increasing clinician confidence, we hope to ultimately expand patient access to cutting-edge, personalized care.”