The US Food and Drug Administration (FDA) has granted 510(k) clearance to GE HealthCare's MIM Software for its Centiloid scaling tool, which is utilized in positron emission tomography (PET)-based amyloid imaging analysis. This advancement will facilitate the quantification of amyloid plaques, a critical indicator of Alzheimer's disease, which currently affects more than six million Americans and is anticipated to nearly double in prevalence by 2050. Beta-amyloid proteins accumulate in the brain, resulting in the formation of amyloid plaques that are linked to neuronal mortality and cognitive decline. The Centiloid scale is used to standardize amyloid results, providing a metric in which amyloid-negative patients are represented by zero and typical Alzheimer's patients by 100. This consistency facilitates the comparability of results across clinical settings and studies.
Andrew Nelson, CEO of MIM Software, GE HealthCare, emphasized the significance of this development, stating, “Alzheimer’s is a far-reaching disease that has been a challenge for our society, patients, caregivers, and healthcare systems for decades.” The integration of the instrument into MIMneuro simplifies the process of generating and interpreting quantitative data, thereby automating the workflow. Included in GE HealthCare's comprehensive array of Alzheimer's care products is this innovation, which encompasses diagnosis and treatment monitoring.
