FDA clearance for amyloid imaging software in Alzheimer’s disease

GE HealthCare’s MIM Software division has received FDA clearance for software to image amyloid plaque in the brains of people with Alzheimer’s disease.

The automated MIMneuro programme analyses PET images from any scanner using injectable tracer agents with the aim of providing a standardised metric for one of the main aspects of Alzheimer’s pathology.

It aims to offer consistent measurements of brain tissue across various scanners and ranges from a score of 0 among people highly likely to have no amyloid buildups, to a high of 100 that represents the typical patient with Alzheimer’s.

With advances in pharmaceutical therapies over the past 18 months—including the FDA’s approvals of Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla — GE HealthCare has been positioning itself to provide the diagnostic support required before treatment.

PET imaging can help clinicians more confidently determine a patient’s amyloid status

Anja Mett, GE HealthCare’s global product leader for MI neurology