FDA greenlights GE SPECT agent for Parkinson's

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The FDA has approved GE Healthcare’s DaTscan (Ioflupane I 123 Injection), a radiopharmaceutical agent intended for use with SPECT imaging, for the detection of dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes.

The diagnostic imaging agent to help physicians evaluate neurodegenerative movement disorders, such as idiopathic Parkinson’s disease, DaTscan may be used as an adjunct to other diagnostic evaluations to help differentiate essential tremor (an involuntary shaking of the hands, head and face) from tremor due to Parkinsonian syndromes. The company noted that DaTscan cannot differentiate between the different types of Parkinsonian syndromes.

The FDA’s action, following a priority review, marks the approval of the first radiopharmaceutical agent to detect DaT distribution within the brain (dopamine is a brain chemical that is classified as a neurotransmitter and is found in regions of the brain that regulate activities such as movement and emotion). Visualization of DaT distribution within the brain may help decrease diagnostic uncertainty in adult patients with suspected Parkinsonian syndromes.