India, June 24 -- GE HealthCare (GEHC) announced that the U.S. Food and Drug Administration has approved an updated label for its positron emission tomography or PET imaging agent Vizamyl (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.
Up 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 ...