FDA Expands Use of GE’s Vizamyl for Alzheimer’s Diagnosis and Monitoring

The U.S. Food and Drug Administration has approved expanded use of GE HealthCare’s beta-amyloid imaging agent, Vizamyl (flutemetamol F 18 injection), marking a significant development for diagnosing and monitoring neurodegenerative diseases.

In a statement released Monday, GE HealthCare called the FDA’s decision “meaningful” for individuals impacted by conditions like Alzheimer’s disease.

“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 Jit Saini, MD, chief medical officer of GE HealthCare’s pharmaceutical diagnostics division. “These changes pave the way for clinicians to expand their usage of Vizamyl, with meaningful implications for patients and their families—helping provide clearer answers, earlier diagnoses and enabling more personalized treatment strategies.”

Previously, Vizamyl was primarily used to visualize amyloid plaque buildup in the brain—a key marker of Alzheimer’s disease. With the FDA’s expanded indications, the imaging agent can now be used to quantify plaque levels and monitor their progression over time. This allows for more objective assessments and helps guide more precise diagnoses.

In addition, the update enhances physicians’ ability to evaluate the effectiveness of amyloid-targeted therapies and modify treatment plans accordingly.

“The use of quantification in amyloid PET imaging has steadily moved from research to clinical practice, where it can aid in more confident and accurate diagnosis,” noted Phillip Kuo, MD, PhD, section chief of nuclear medicine and director of theranostics at City of Hope National Medical Center in California. “Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer's disease and determining when it can be discontinued.”

The updated approval also lifts previous restrictions on using Vizamyl to help assess whether cognitive impairment may progress into Alzheimer’s disease, further broadening its clinical utility.