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SPECT Imaging Agent Gets Expanded FDA Approval for Patients with Suspected Dementia with Lewy Bodies


GE Healthcare’s DaTscan is reportedly the first radiopharmaceutical tracer agent approved by the Food and Drug Administration (FDA) for use in patients with suspected dementia with Lewy bodies.

An emerging imaging agent utilized with single photon emission computed tomography (SPECT) may help improve the detection of dementia with Lewy bodies, which affects approximately 20 percent of people with dementia and is reportedly misdiagnosed in 70 percent of these patients due to overlapping symptoms and signs with other neurodegenerative diseases.1,2

DaTscan (GE Healthcare) was recently granted an expanded approval by the Food and Drug Administration (FDA) for use in patients with suspected dementia with Lewy bodies.3 GE Healthcare said DaTscan is the first radiopharmaceutical tracer agent to be approved by the FDA for this condition.

James E. Galvin, M.D., M.P.H., said the expanded FDA approval for DaTscan may help prevent delayed diagnosis and facilitate earlier treatment intervention for people with Lewy body dementia.

“The label expansion for DaTscan moves patients a step closer to an earlier, more accurate diagnosis, which is beneficial for them and their families, setting them on the right treatment path sooner and helping them to avoid medications and treatments that could be potentially harmful,” noted Dr. Galvin, chief of the Division of Cognitive Neurology and director of the Lewy Body Dementia Research Center of Excellence at the University of Miami Miller School of Medicine.

DaTscan was previously approved by the FDA for the visualization of dopamine transporters on SPECT imaging in adults with suspected Parkinsonian syndromes, according to GE Healthcare.


1. Barker WW, Luis CA, Kashuba A, et al. Relative frequencies of Alzhemier disease, Lewy body, vascular and frontotemporal dementia, and hippocampal sclerosis in the State of Florida Brain Bank. Alzheimer Dis Assoc Disord. 2002;16(4):203-212.

2. Warr L, Walker Z. Identification of biomarkers in Lewy-body disorders. Q J Nucl Med Mol Imaging. 2012;56(1):39-54.

3. GE Healthcare. DATSCAN (Ioflupane I 123 injection) indication expanded to include use in patients with suspected dementia with Lewy bodies (DLB). Business Wire. Available at: https://www.businesswire.com/news/home/20221103005731/en/DATSCAN%E2%84%A2-Ioflupane-I-123-Injection-indication-expanded-to-include-use-in-patients-with-suspected-Dementia-with-Lewy-Bodies-DLB . Published November 3, 2022. Accessed November 16, 2022.

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