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GE Healthcare Says FDA Okays Vizamyl For Detection Of Beta Amyloid

GE Healthcare (GE) Friday announced the U.S. Food and Drug Administration approval of Vizamyl (Flutemetamol F18 injection), a radioactive diagnostic agent indicated for Positron Emission Tomography 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 or other causes of cognitive decline.

Vizamyl is an adjunct to other diagnostic evaluations. Vizamyl is the only Positron Emission Tomography, or PET imaging tracer for detection of amyloid approved by FDA for visual interpretation of color images rather than black and white assessment, and will be commercially available in 2014.

Increased levels of beta amyloid plaque is a defining pathological feature of Alzheimer's disease, the most common form of dementia and the sixth leading cause of death in the United States.

Normally, beta amyloid is broken down and eliminated, but in individuals with Alzheimer's disease, amyloid plaque builds up and can negatively impact neuronal function.

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