DaT's good enough

By backing DaTSCAN ioflupane I123 injection from GE Healthcare last week, an FDA panel indicated that a molecular imaging agent that allows physicians to see abnormal changes in the brain has clinical value, and that the hurdle for such agents should be different than the hurdle for those seeking claims for the diagnosis of specific diseases.

FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 11-2, with one abstention, that the risk-benefit profile of DaTSCAN supports its use as an adjunct to clinical assessment for evaluation of patients with symptoms or signs suggestive of dopaminergic neurodegeneration...