EU approval for GE's VIZAMYL

The European Union (EU) has approved GE's VIZAMYL (Flutemetamol (18F) Solution for Injection), a PET imaging system

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It is a one-of its kind PET imaging tracer for the detection of amyloids that has received EU approval

GE healthcare's radiopharmaceutical product VIZAMYL (flutemetamol (18F)) a Positron Emission Tomography (PET) imaging system, used to detect amyloid plagues has received the European Union's approval. It is the only PET imaging tracer that has been approved by the regulatory body. However, 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 authorisation for VIZAMYL in the European Union (EU) demonstrates our continued commitment to help meet this challenge and support the diagnosis of Alzheimer's disease" said Mr Kieran Murphy, president and CEO, Lifesciences, GE Healthcare. He added, "This approval will provide physicians in EU with an important tool that may help them better assess specific patients, who are being evaluated for Alzheimer's disease and will also support further research into greatly needed disease modifying agents."

VIZAMYL can detect the accumulation of beta amyloid in the brain, which will help confirm an Alzheimer diagnosis and also in determining appropriate treatment plans.

It will be commercially available in Europe from early next year.

 

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