GE HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its PET imaging agent Vizamyl™ (flutemetamol F 18 injection), used for detecting beta-amyloid plaques in the brain—a hallmark of Alzheimer’s disease. The revised label expands the agent’s indications, enables quantitative analysis of scans, and removes previous limitations on monitoring patient response to anti-amyloid therapies.
Previously, Vizamyl and similar amyloid diagnostics provided only a visual assessment of amyloid plaque buildup. The new approval allows clinicians to use quantitative software tools that calculate the amyloid load, improving diagnostic confidence and consistency, supported by published research. This advancement facilitates a more objective evaluation of disease progression and therapy effectiveness.
Importantly, the updated label permits Vizamyl to be used for assessing whether anti-amyloid treatment has sufficiently reduced plaque levels, supporting decisions on continuing or stopping therapy—an option that was restricted before.
Dr. Jit Saini, Chief Medical Officer of GE HealthCare’s Pharmaceutical Diagnostics division, emphasized the significance: “These label changes enable timely, appropriate care decisions, providing clearer answers and more personalized treatment strategies for patients and families.”
Experts echo the impact of this advancement. Dr. Phillip Kuo of City of Hope National Medical Center noted that quantification in amyloid PET imaging is transitioning from research to clinical use, enhancing diagnosis accuracy and aiding treatment initiation and monitoring.
The label update also explicitly allows Vizamyl’s use in selecting patients eligible for therapy and removes previous restrictions on diagnosing Alzheimer’s disease. The new criteria align with the Alzheimer’s Association’s revised guidelines, recognizing an abnormal amyloid PET scan as sufficient for diagnosis. Moreover, the update eliminates limitations related to predicting cognitive decline or dementia progression, reflecting evidence linking amyloid-positive scans to a higher risk of advancing Alzheimer’s.
First approved in 2013, Vizamyl estimates beta amyloid neuritic plaque density in adults with cognitive impairment. GE HealthCare complements this with quantitative analysis tools, such as its FDA-cleared MIMneuro application, enhancing scan interpretation and standardization.
GE HealthCare’s Pharmaceutical Diagnostics division supports approximately 130 million imaging procedures annually worldwide, providing key tools across cardiology, neurology, and oncology to improve diagnosis, treatment decisions, and clinical outcomes.