by
Gus Iversen, Editor in Chief | June 25, 2025
The FDA has approved expanded indications for GE HealthCare’s Vizamyl (flutemetamol F 18 injection), allowing broader clinical use in Alzheimer’s disease diagnosis and treatment monitoring.
The updated label enables not only the visualization but also quantification of beta-amyloid plaque burden in the brain, offering a more objective and continuous method for assessing disease progression and therapeutic response.
GE HealthCare can now market Vizamyl for several additional uses, including identifying patients eligible for anti-amyloid therapies, establishing a diagnosis of Alzheimer’s disease, and predicting progression to dementia. Previously, the agent had been limited to visual estimation of amyloid plaque density in cognitively impaired adults.
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A key change is the removal of a restriction that barred use of Vizamyl for monitoring treatment response. The revised label now supports its application in determining whether amyloid plaque levels have decreased enough to potentially discontinue therapy. This shift aligns with recent research suggesting that quantification improves diagnostic consistency and may help guide more precise care decisions.
“The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients, further enabling timely and appropriate care decisions,” said Dr. Jit Saini, chief medical officer of GE HealthCare’s pharmaceutical diagnostics division.
The label update reflects evolving diagnostic standards, including revised Alzheimer’s Association criteria, which recognize that an abnormal amyloid PET scan alone can support a diagnosis of Alzheimer’s disease. The new labeling also acknowledges evidence that amyloid-positive scans are predictive of future cognitive decline, particularly in patients with mild cognitive impairment.
Vizamyl was first approved by the FDA in 2013. Quantification of Vizamyl scans can now be performed using FDA-cleared tools such as GE HealthCare’s MIM Neuro Software platform, which includes centiloid scaling capabilities.
