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GE Healthcare DaTscan wins FDA approval

GE Healthcare has received the US Food and Drug Administration (FDA) approval for DaTscan (Ioflupane I 123 Injection), a diagnostic imaging agent to help physicians evaluate neurodegenerative movement disorders, such as idiopathic Parkinson's disease (PD).

DaTscan is a radiopharmaceutical agent intended for use with single photon emission computed tomography (SPECT) imaging, for the detection of dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes (PS).

DaTscan may be used as an adjunct to other diagnostic evaluations to help differentiate essential tremor from tremor due to PS, but cannot differentiate between the different types of PS.

The FDA’s approval of DaTscan was based on two Phase 3 clinical trials confirming the efficacy of DaTscan for the visualization of DaT distribution within the brain.

GE Healthcare Medical Diagnostics MI-SPECT Segment leader Stephen Lightfoot said the DaTscan, an objective and accurate marker of dopamine transporters, will better inform physicians’ diagnostic decisions.

"By potentially enabling better disease management, we expect that DaTscan will greatly benefit the patient community," Lightfoot said.