Imaging centers near East Rutherford, NJ; Woburn, MA; Beltsville, MD; East Lansing, MI; Dallas; Phoenix; and Colton, CA, will be able to purchase the radiopharmaceutical late in the second quarter, according to the vendor. Vizamyl (flutemetamol F-18 injection) is indicated for PET brain imaging 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.
GE received U.S. Food and Drug Administration (FDA) approval for Vizamyl in October 2013. The company noted that Vizamyl is an adjunct to other diagnostic evaluations and that its safety and effectiveness have not been established for predicting the development of dementia or other neurologic conditions, or for monitoring response to therapies.
In a related development, GE has also launched an electronic reader training program that trains physicians on the appropriate method for interpreting Vizamyl images. The images should be interpreted only by readers who have completed the training program, the company said.