GE HealthCare (GEHC) MIM Software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to offer its MIMneuro software with Centiloid scaling to patients being evaluated for Alzheimer’s disease.
MIM Software’s Centiloid scaling tool has been validated for positron emission tomography (PET)-based amyloid imaging analysis and quantification. The approach aims to increase clinicians’ confidence in determining amyloid plaque density—a key indicator of Alzheimer’s disease pathology—in a patient’s brain.
Centiloid scaling provides a standardized metric against which amyloid results can be compared, with zero representing the mean value in high-confidence patients and 100 representing the mean value typically seen in patients with Alzheimer’s disease.
The company claims that MIMneuro supports the Centiloid scaling tool by providing automated workflows that guide users through the process of generating and understanding the Centiloid scaling result. By taking the PET amyloid images, the software instructs clinicians to generate quantitative results, with the data presented in a standardized report that clinicians can view along with the images.
GEHC MIM Software CEO Andrew Nelson commented: “Centiloid scaling with MIMneuro provides a standardized, quantitative metric to help healthcare providers confidently estimate the density of amyloid plaques, a key feature of Alzheimer’s disease. By increasing clinicians’ confidence, we hope to ultimately expand patients’ access to advanced, personalized care.”
GEHC completed the acquisition of MIM Software, a suite of image analysis and digital workflow solutions, in April 2024. The company said the acquisition aligns with its precision care strategy, with the overall goal of delivering a suite of digital care pathway solutions for more precise, connected and efficient care across all disease states.
GlobalData predicts the global Alzheimer’s market will be worth $15.9 billion by 2030, with more than 70 in vitro diagnostic agents for Alzheimer’s currently in development.
This year, the Alzheimer’s space has seen a flurry of activity in the development and launch of Tau biomarker tests. Along with amyloid beta, Tau is a key protein implicated in the disease.
In April, Roche received breakthrough designation from the FDA for its Tau biomarker test, and last month, Genova and Neurocode partnered to develop a Tau blood test for the early detection of Alzheimer’s.
“GE HealthCare’s MIM Software Receives FDA Clearance for Alzheimer’s Diagnostics” was originally created and published by Medical Device Network, a GlobalData brand.
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