• The FDA has approved an updated label for Vizamyl (flutemetamol F 18 injection), including quantification which enables a more continuous and objective measure of amyloid in the brain
• This approval also enables clinicians to use Vizamyl to monitor patient response to anti-amyloid therapies
• Other updates include now enabling the use of Vizamyl to predict development of dementia or other cognitive decline due to Alzheimer's disease, selecting patients who are indicated for anti-amyloid therapies, and establishing a diagnosis of Alzheimer's disease.
• The updated label enables enhanced decision making, and more confident diagnosis and monitoring of Alzheimer's disease, helping patients and their families access timely, precision care.

GE HealthCare (NASDAQ:GEHC) today 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.