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GE HealthCare's MIM Software Receives FDA Clearance for New Centiloid Scaling Tool to Quantify Amyloid Plaque in Brain Imaging

NextEdge Admin

19 Sep 2024

2 min 57 sec

GE HealthCare’s MIM Software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Centiloid scaling tool, designed to quantify amyloid plaque in positron emission tomography (PET) brain imaging. The tool is integrated with MIMneuro, a vendor-neutral platform that assists clinicians in assessing amyloid plaque density, a key biomarker in Alzheimer’s disease.

Alzheimer’s disease accounts for 60-80% of dementia cases, affecting over 6 million Americans. This number is projected to reach nearly 13 million by 2050. Alzheimer’s progressively impairs memory, cognition, and behavior, leading to severe impairment that disrupts daily life. A significant hallmark of the disease is the accumulation of beta-amyloid plaques, which is associated with brain cell death and tissue loss. The ability to quantify these plaques is crucial for diagnosis and treatment.

Recent advancements in amyloid-targeting therapies offer new hope, showing potential to slow cognitive decline in Alzheimer’s patients. PET imaging plays a critical role in identifying candidates for these treatments by visualizing and quantifying amyloid protein. To standardize amyloid imaging results across different tracers and institutions, the Centiloid scale was developed by an international team of experts. The scale ranges from zero, representing amyloid-negative patients, to 100, representing typical Alzheimer’s cases.

MIMneuro with Centiloid scaling provides an automated workflow that helps clinicians generate and interpret quantitative results. The software takes PET amyloid images and produces standardized reports, enhancing clinician confidence in estimating plaque density. This, in turn, can improve decision-making for amyloid-targeting therapies.

“Centiloid scaling with MIMneuro offers a standardized metric to help clinicians confidently estimate amyloid plaque density,” said Andrew Nelson, CEO of MIM Software, GE HealthCare. This innovation aims to broaden patient access to personalized Alzheimer’s care and contribute to the growing portfolio of GE HealthCare’s solutions for the Alzheimer’s disease care pathway.