GE HealthCare Receives FDA Clearance for Alzheimer’s Imaging Tool

What You Should Know: 

– GE HealthCare announced today that its MIM Software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a groundbreaking tool in the fight against Alzheimer’s disease. 

– The advancement allows MIMneuro, a vendor-neutral software solution, to perform “Centiloid scaling” for analyzing and quantifying amyloid plaque density in the brain using positron emission tomography (PET) imaging.

Impact of Alzheimer’s Disease

Alzheimer’s disease is a devastating neurodegenerative condition affecting millions worldwide. With the global prevalence of dementia increasing every second, accurate and standardized tools for early diagnosis are critical. Amyloid plaque buildup in the brain is a hallmark of Alzheimer’s, and PET imaging plays a crucial role in visualizing these plaques.

The Centiloid scale provides a standardized measurement for amyloid plaque density, enabling clinicians to compare results across different imaging techniques and institutions. This standardization is essential for accurate diagnosis and for identifying patients who may benefit from emerging amyloid-targeting therapies.

How MIMneuro with Centiloid Scaling Work

MIMneuro simplifies the analysis of PET images by guiding clinicians through an automated workflow. This streamlined process generates quantitative results, presented in a standardized report alongside the images. By providing clinicians with easy access to this crucial data, MIMneuro with Centiloid scaling empowers them to make more informed decisions about patient care.

“Alzheimer’s is a far-reaching disease that has been a challenge for our society, patients, caregivers, and healthcare systems for decades,” explains Andrew Nelson, CEO of MIM Software, GE HealthCare. “Centiloid scaling with MIMneuro offers a standardized, quantitative metric to assist healthcare providers in confidently estimating amyloid plaque density, one key aspect of this debilitating disease. By increasing clinician confidence, we hope to ultimately expand patient access to cutting-edge, personalized care.”