FDA expands approval of imaging agent to aid Alzheimer’s diagnosis

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The FDA has approved expanded use of GE HealthCare’s PET imaging agent, Vizamyl, for improved detection and monitoring of Alzheimer’s disease. 

The updated label now allows Vizamyl to be used to detect beta amyloid plaques in the brain and quantify their presence, so clinicians have a more objective way to assess amyloid levels, according to a June 24 news release from GE. 

Previously, Vizamyl was used mainly for visual assessment. With the new approval, it can now help determine whether therapies are effectively reducing amyloid buildup and guide decisions on starting or stopping treatment, the release said. 

Vizamyl was first approved in 2013 to measure amyloid plaque density in adults with cognitive symptoms. 

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