FDA approves expanded indications for GE HealthCare's Vizamyl PET imaging agent for beta amyloid detection, enabling more precise care for Alzheimer's patients
United States, June 24 -- GE HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its positron emission tomography (PET) imaging agent VizamylTM (flutemetamol F 18 injection) for beta-amyloid detection. The revised label, effective immediately, expands the indications for use, enables quantitative analysis of Vizamyl scans, and removes significant previous limitations such as monitoring patient response to anti-amyloid therapy.Up to now, amyloid diagnostics such as Vizamyl have been used to provide a visual assessment of amyloid plaque accumulation in the brain. With quantification now added to the label, clinicians can reach a more objective assessment, using software that enables a calcul...
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