GE Healthcare receives new EU approval for Vizamyl

GE Healthcare has been granted European regulatory approval for Vizamyl, its new radiopharmaceutical medicinal product for use in medical imaging applications.

The agent has been approved for positron emission tomography (PET) imaging of beta amyloid neuritic plaque density in the brains of adult patients who are being evaluated for Alzheimer's disease and other causes of cognitive impairment.

It is the only PET imaging tracer for detection of amyloid approved in Europe for visual interpretation of colour images and has shown high sensitivity and specificity in phase III clinical trials.

Vizamyl will be made commercially available in selected European countries from early 2015 onwards.

Kieran Murphy, president and chief executive officer for life sciences at GE Healthcare, said this approval will provide doctors 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".

This follows the launch of the company's Vscan with Dual Probe pocket-sized ultrasound device last month.