Siemens Healthineers gets FDA nod, CE Mark for two new Alzheimer's PET software features
October 23, 2024
by
Gus Iversen, Editor in Chief
Siemens Healthineers has introduced two new features to its syngo.PET Cortical Analysis software, aimed at enhancing the diagnosis and monitoring of Alzheimer's disease.
The updates, Centiloid scoring and tau PET quantification, both recently received CE Mark approval in Europe and FDA clearance in the U.S.
The Centiloid scoring feature standardizes the measurement of beta-amyloid plaques across different PET scanners and radiopharmaceuticals, using a 100-point scale. This standardization is especially significant following the FDA approval of drugs designed to reduce cognitive decline by targeting beta-amyloid in Alzheimer's patients. With Centiloid scoring, clinicians can compare amyloid plaque levels from various imaging systems, improving diagnostic consistency and aiding in both patient management and clinical trial design.
The second feature, tau PET quantification, assesses the distribution and density of tau protein tangles in the brain using the radiopharmaceutical flortaucipir. Tau pathology, which correlates with cognitive decline, is classified based on Braak staging, a six-stage model. This capability is crucial in evaluating the severity of Alzheimer's disease and plays a pivotal role in trials for investigational tau-targeted therapies.
Both features bolster Siemens Healthineers' software portfolio, supporting the detection, diagnosis, and management of Alzheimer's disease.
According to Martin Cordell, Ph.D., director of product life cycle management at Siemens Healthineers, these advancements offer clinicians "important diagnostic and staging information" for Alzheimer’s disease patients, aiding in the overall care continuum.