FDA grants 510(k) clearance to amyloid imaging tool

The FDA has granted 510(k) clearance to a Centiloid scaling apparatus software for positron emission tomography-based amyloid imaging to evaluate individuals for Alzheimer’s disease-related pathology.

According to a press release from GE HealthCare, its MIM Software Centiloid scale tool was developed to more accurately assess the density of amyloid plaque in a patient’s brain. Accumulation of amyloid protein has been linked to cell death, tissue loss and cognitive decline for individuals diagnosed with AD.

The software allows clinicians to generate quantitative results from PET amyloid images. It presents standardized data that can be reviewed concurrently with PET images.

The scale itself offers a standardization metric for PET results, with zero representing the average value from individuals who are amyloid-negative and 100 representing the average value from those with AD, the company said.

“Alzheimer’s is a far-reaching disease that has been a challenge for our society, patients, caregivers, and health care systems for decades,” Andrew Nelson, CEO of MIM Software, stated in the release “Centiloid scaling with MIMneuro offers a standardized, quantitative metric to assist health care providers in confidently estimating amyloid plaque density, one key aspect of this debilitating disease.”