GE HealthCare’s Brain Imaging Tool For Alzheimer’s Wins FDA Nod

GE HealthCare’s Brain Imaging Tool For Alzheimer’s Wins FDA Nod

GE HealthCare’s MIM Software has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Centiloid scaling for positron emission tomography (PET)-based amyloid imaging analysis and quantification.
 
The new tool is available with MIMneuro, a vendor-neutral solution. The Centiloid scale tool aims to help confidently determine the density of amyloid plaque in the patient’s brain. Amyloid plaque is a components of Alzheimer’s disease pathology.
 
PET imaging helps visualize and quantify amyloid protein to help identify candidates for amyloid-targeting treatments. An international team of clinicians and researchers developed the Centoloid scale to standardize amyloid imaging analysis across radiotracers and institutions.
 
MIMneuro with Centiloid scaling leverages an automated workflow to guide users through generating and understanding the quantitative result. The software takes PET amyloid images, provides instructions to automatically generate quantitative results, and presents the data in a standardized report for viewing alongside the images.
 
“Alzheimer’s is a far-reaching disease that has been a challenge for our society, patients, caregivers, and healthcare systems for decades,” explained 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.” 
 
“As amyloid-targeting therapies continue to show meaningful results against Alzheimer’s disease, PET imaging can help clinicians more confidently determine a patient’s amyloid status,” added Anja Mett, Global Product Leader, MI Neurology, GE HealthCare. “MIM Software’s new Centiloid scaling solution in MIMneuro is the latest addition to our growing portfolio of GE HealthCare Alzheimer’s disease care pathway solutions: including MR and PET scanners, and our amyloid PET tracer – combined with our digital solutions. Altogether, we are uniquely positioned to provide integrated solutions to our customers in this highly regulated industry, with the potential to support strong procedure growth and the overall growth in diagnostic and molecular imaging.”

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