GE Healthcare secures FDA clearance for MIM Software Centiloid scaling

GE HealthCare’s (GEHC) MIM Software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to perform Centiloid scaling for PET-based amyloid imaging analysis and quantification.

MIM Software may now offer its MIMneuro package with Centiloid scaling, which uses an automated workflow to help users determine the density of amyloid plaque in a patient’s brain, GEHC said. Amyloid plaque density is one component of Alzheimer’s disease pathology.

The Centiloid scale provides a standardized metric to compare amyloid results, with 0 representing the average value from high-certainty amyloid-negative patients and 100 representing the average value from typical patients with Alzheimer’s disease, according to GEHC.