The FDA 510(k) clearance covers performing Centiloid scaling for positron emission tomography (PET)-based amyloid imaging analysis and quantification. Available with MIMneuro – a vendor-neutral solution – the new Centiloid scale tool can help clinicians more confidently determine the density of amyloid plaque in a patient’s brain, according to GE HealthCare.
Amyloid plaque density is one of the things that clinicians look at when assessing Alzheimer’s disease.
“Alzheimer’s is a far-reaching disease that has been a challenge for our society, patients, caregivers, and healthcare systems for decades,” Andrew Nelson, CEO of MIM Software at GE HealthCare, said in a news release. “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.”
The new imaging tool is winning clearance at the same time that pharmaceutical companies are releasing new therapies onto the market to help treat the condition, such as Eli Lilly’s Kisunla (donanemab-azbt) and Eisai and Biogen’s Lequembi (lecanemab-irmb).
“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,” said Anja Mett, global product leader of MI Neurology at 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.”