GE Healthcare’s Vizamyl received CHMP recommendation

GE Healthcare has announced that Vizamyl, its new radiopharmaceutical medicinal product, has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the product for approval for use in positron emission tomography (PET) imaging of beta amyloid neuritic plaques.

Medical professionals gauge the density of these plaques in the brains of adult patients to help detect evidence of Alzheimer's disease and other causes of cognitive impairment. Vizamyl can be used in conjunction with a clinical evaluation to produce more effective diagnostic processes.

The product has shown its efficacy in clinical trials and is already approved for this purpose in the US.

Kieran Murphy, president and chief executive officer for life sciences at GE Healthcare, said: "The CHMP positive recommendation further strengthens GE Healthcare's longstanding commitment to the early and accurate detection of AD pathology and to improving quality of life for patients and their caregivers."

This comes after the company received CE Mark approval for its Omnyx Integrated Digital Pathology solution with VL120 high volume scanner last month.