GE HealthCare’s MIM Software has received FDA 510(k) clearance for its MIMneuro software with Centiloid scaling. This tool helps clinicians evaluate amyloid PET scans in patients being assessed for Alzheimer’s disease. Centiloid scaling provides a standardized measure of amyloid plaque density, a key indicator of Alzheimer’s.
The scale ranges from zero, representing the average value for amyloid-negative patients, to 100, indicating the typical value in Alzheimer’s patients. The MIMneuro software offers automated workflows to guide users through generating and interpreting Centiloid scaling results. It takes PET amyloid images and produces quantitative results, providing healthcare providers with a standardized report to review alongside the images.
MIMneuro software’s Centiloid scaling approved
Andrew Nelson, CEO of GE HealthCare MIM Software, said, “Centiloid scaling with MIMneuro offers a standardized, quantitative metric to assist healthcare providers in confidently estimating amyloid plaque density, one key aspect of Alzheimer’s disease. By increasing clinician confidence, we hope to expand patient access to cutting-edge, personalized care ultimately.
GE Healthcare acquired MIM Software, which provides imaging analytics and digital workflow solutions, in April 2024.
The acquisition supports GE HealthCare’s precision care strategy, aiming to deliver digital solutions for precise, connected, and efficient care across various disease states. This development comes as the global Alzheimer’s disease market is projected to reach $15.9 billion by 2030, with significant activity in developing both amyloid beta and Tau biomarker tests. Roche recently secured FDA breakthrough designation for its Tau blood test for early Alzheimer’s detection.
GE HealthCare’s approval marks a significant milestone in expanding diagnostic tools available to clinicians in the fight against Alzheimer’s. It represents a step toward more personalized and accurate patient care.
