Business
FDA Approves Expanded Indications for GE HealthCare’s Vizamyl PET Imaging Agent for Beta Amyloid Detection, Enabling More Precise Care for Alzheimer’s Patients
The FDA has approved an updated label for Vizamyl (flutemetamol F 18 injection), including quantification which enables a more continuous and objective
About this update from Ge Healthcare Technologies Inc.
[{"type":"text","content":"\n\nThe 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\n\n\n\nThis approval also enables clinicians to use Vizamyl to monitor patient response to anti-amyloid therapies\n\n\n\nOther 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.\n\n\n\nThe 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.\n\n\n\n ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--\nGE 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.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250624101667/en/PET brain scan using Vizamyl (flutemetamol F18) with quantification software\nUp 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 calculation of amyloid load, with published research demonstrating that quantification improves diagnostic confidence and consistency among readers1,2,3. In addition, with the removal of a limitation of use for monitoring therapy effectiveness, Vizamyl can also now be used to assess whether the level of amyloid plaques has been reduced sufficiently for the therapy to potentially be stopped.\n\n\n“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 ...