GE gets FDA nod for DaTscan

GE Healthcare has received U.S. Food and Drug Administration (FDA) clearance for its DaTscan (ioflupane I-123 injection) radiopharmaceutical agent.

Used with SPECT scans, DaTscan is designed for the detection of dopamine transporters in the brains of adult patients with suspected Parkinsonian syndromes, according to the Chalfont St. Giles, U.K.-based vendor. DaTscan can help physicians evaluate neurodegenerative movement disorders, such as idiopathic Parkinson's disease; it may be used as an adjunct to other diagnostic evaluations to help differentiate essential tremor from tremor due to Parkinsonian syndromes, GE said.

The FDA cleared DaTscan after reviewing the radiopharmaceutical in its priority review program, GE said.

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