GE Healthcare Announces FDA Approval of Vizamyl(™) (Flutemetamol F18 Injection) for Detection of Beta Amyloid

Circle Connections: Policy & Regulatory Updates GE Healthcare today announced the U.S. Food and Drug Administration (FDA) approval of Vizamyl(™) (Flutemetamol F18 injection), a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of cognitive decline. Vizamyl is an adjunct to other diagnostic evaluations. Vizamyl is the only PET imaging tracer for detection of amyloid approved by FDA for visual interpretation of color images rather than black and white assessment . . .