GE HealthCare’s MIM Software has announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Centiloid scaling tool, designed for PET-based amyloid imaging analysis and quantification. Integrated with MIMneuro—a vendor-neutral solution—this tool aims to enhance clinicians’ ability to accurately assess amyloid plaque density in the brain, a key marker of Alzheimer’s disease pathology.
Alzheimer’s disease accounts for 60-80% of dementia cases, with a new case developing every three seconds worldwide. In the U.S., over 6 million people currently live with Alzheimer’s, and this number is expected to approach 13 million by 2050. The disease impairs memory, thinking, and behavior, beginning with mild cognitive impairment and progressing to severe interference with daily activities.
A defining feature of Alzheimer’s is the buildup of beta-amyloid protein in the brain, leading to cell death and tissue loss. Recent advancements in amyloid-targeting treatments have shown promise in slowing cognitive decline for some patients, providing new hope for affected individuals and their families.
Andrew Nelson, CEO of MIM Software, GE HealthCare, commented, “Alzheimer’s is a pervasive issue affecting society, patients, caregivers, and healthcare systems. The Centiloid scaling tool with MIMneuro provides a standardized, quantitative measure to help healthcare providers accurately estimate amyloid plaque density. By bolstering clinician confidence, we aim to enhance patient access to advanced, personalized care.”
PET imaging allows for the visualization and quantification of amyloid proteins, helping clinicians identify candidates for amyloid-targeting therapies. To standardize this analysis, an international team developed the Centiloid scale, which provides a consistent metric for comparing amyloid results—zero indicating average values in amyloid-negative patients and 100 representing average values in typical Alzheimer’s patients.
The new Centiloid scaling feature in MIMneuro simplifies the process by automating the workflow to generate and interpret quantitative results. It processes PET amyloid images, provides automated instructions for generating results, and presents data in a standardized report for clinician review, making it easier to access and evaluate patient data.
Anja Mett, Global Product Leader for MI Neurology at GE HealthCare, stated, “As amyloid-targeting therapies continue to demonstrate efficacy against Alzheimer’s, PET imaging can help clinicians more accurately assess a patient’s amyloid status. MIM Software’s Centiloid scaling tool is a valuable addition to our Alzheimer’s care pathway solutions, complementing our MR and PET scanners and amyloid PET tracer. This comprehensive approach positions us to support robust procedure growth and advancements in diagnostic and molecular imaging.”
MIMneuro with Centiloid scaling represents the latest advancement in GE HealthCare’s extensive suite of products and solutions addressing the Alzheimer’s disease care pathway from diagnosis to treatment monitoring. GE HealthCare remains committed to advancing healthcare by fostering collaboration across therapeutic, diagnostic, and scientific communities to ensure accessible and effective care for all.
