News | September 02, 2014

GE Healthcare Gains European Approval of Vizamyl PET Imaging Agent for Alzheimer’s Disease

PET imaging agent receives marketing authorization from European Commission

Vizamyl PET cases showing examples of negative flutemetamol (18F) PET scan (left) and positive scan (right).

September 2, 2014 — GE Healthcare announced that the Vizamyl flutemetamol (18F) solution for injection has received marketing authorization from the European Commission as a radiopharmaceutical medicinal product indicated for positron emission tomography (PET) imaging of beta amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment.

Vizamyl is the only PET imaging tracer for the detection of amyloid approved in Europe for visual interpretation of color images and will be commercially available in selected European countries from early 2015. Vizamyl is for diagnostic use only and should be used in conjunction with a clinical evaluation.

“Dementia is one of the biggest health and social challenges in the world and receiving marketing authorization for Vizamyl in the European Union demonstrates our continued commitment to helping to meet this challenge and support the diagnosis of Alzheimer’s disease,” said Kieran Murphy, president and CEO, Life Sciences, GE Healthcare. “This approval will provide physicians in the EU with an important tool that may help them better assess specific patients who are being evaluated for AD and will also support further research into greatly needed disease modifying agents.”

Alzheimer's disease, the leading cause of dementia, can be challenging to diagnose, as many of the symptoms are similar to other causes of cognitive impairment. When used in conjunction with a clinical evaluation, using Vizamyl to detect the accumulation of beta amyloid in the brain may help to confirm an AD diagnosis and could potentially have an impact on earlier patient management, including the treatment of symptoms.

“Vizamyl can help with diagnosis in certain individuals, providing patients and caregivers, along with their healthcare professionals, the opportunity to determine appropriate treatment options and plan for the future,” said Philip Scheltens, M.D., Ph.D., professor of cognitive neurology and director of the Alzheimer Center at the VU University Medical Center, Amsterdam. “Because AD and dementia continue to be a major burden on healthcare and society, it is equally important that Vizamyl will help support and guide further clinical research that is vital in order to develop disease modifying agents.”

The marketing authorization for Vizamyl was based on review of data from a series of Phase III clinical trials, including brain autopsy studies which showed high sensitivity and specificity for visual interpretation of flutemetamol (18F) PET images, using beta amyloid pathology as the standard of truth. Additionally, to instruct physicians in accurate interpretation of Vizamyl images, GE Healthcare has developed an electronic reader training program (ETP), which, following approval, will be offered free of charge as online and in-person training in the EU. Images should be interpreted only by readers who have completed the GE Healthcare electronic reader training program.

For more information: www.gehealthcare.com

Related Content

Study Explores Magnetic Nanoparticles as Bimodal Imaging Agent for PET/MRI

Image courtesy of MR Solutions.

News | PET-MRI | May 23, 2019
Researchers from Bourgogne University in Dijon, France, showed that use of superparamagnetic iron oxide nanoparticles (...
Henry Ford Hospital's ViewRay MRIdian linear accelerator system allows real-time MRI-guided radiotherapy. Shown is the support staff for this system. In the center of the photo is Benjamin Movsas, M.D., chair of radiation oncology at Henry Ford Cancer Institute. Second from the right is Carrie Glide-Hurst, Ph.D., director of translational research, radiation oncology.

Henry Ford Hospital's ViewRay MRIdian linear accelerator system allows real-time MRI-guided radiotherapy. Shown is the support staff for this system. In the center of the photo is Benjamin Movsas, M.D., chair of radiation oncology at Henry Ford Cancer Institute. Second from the right is Carri Glide-Hurst, Ph.D., director of translational research, radiation oncology.

Feature | Henry Ford Hospital | May 21, 2019 | Dave Fornell, Editor
Henry Ford Hospital thought leaders regularly speak at the radiation oncology and radiology conferences about new res
MaxQ AI Launches Accipio Ax Slice-Level Intracranial Hemorrhage Detection
Technology | Computer-Aided Detection Software | May 21, 2019
Medical diagnostic artificial intelligence (AI) company MaxQ AI announced that Accipio Ax will begin shipping in August...
New Study Evaluates Head CT Examinations and Patient Complexity
News | Neuro Imaging | May 17, 2019
Computed tomography (CT) of the head uses special X-ray equipment to help assess head injuries, dizziness and other...
Brain images that have been pre-reviewed by the Viz.AI artificial intelligence software to identify a stroke. The software automatically sends and alert to the attending physician's smartphone with links to the imaging for a final human assessment to help speed the time to diagnosis and treatment. Depending on the type of stroke, quick action is needed to either activate the neuro-interventional lab or to administer tPA. Photo by Dave Fornell.

Brain images that have been pre-reviewed by the Viz.AI artificial intelligence software to identify a stroke. The software automatically sends and alert to the attending physician's smartphone with links to the imaging for a final human assessment to help speed the time to diagnosis and treatment. Depending on the type of stroke, quick action is needed to either activate the neuro-interventional lab or to administer tPA. Photo by Dave Fornell.

Feature | Artificial Intelligence | May 17, 2019 | Inga Shugalo
With its increasing role in medical imaging,...
New Phase 2B Trial Exploring Target-Specific Myocardial Ischemia Imaging Agent
News | Radiopharmaceuticals and Tracers | May 17, 2019
Biopharmaceutical company CellPoint plans to begin patient recruitment for its Phase 2b cardiovascular imaging study in...
Videos | Advanced Visualization | May 16, 2019
This is an example of how virtual reality is being used in neuro-radiology to better evaluate patients using advanced
Blue Earth Diagnostics Expands Access to Axumin in Europe
News | Radiopharmaceuticals and Tracers | May 13, 2019
Blue Earth Diagnostics announced expanded access to the Axumin (fluciclovine (18F)) imaging agent in Europe. The first...
Shine Medical Technologies Breaks Ground on U.S. Medical Isotope Production Facility

Image courtesy of Amen Clinics

News | Radiopharmaceuticals and Tracers | May 10, 2019 | Jeff Zagoudis, Associate Editor
Shine Medical Technologies Inc. broke ground on their first medical isotope production facility in Janesville, Wis. U.S...