FDA approves AdreView (GE HealthCare) for gamma scintigraphic assessment of Heart Failure
The FDA has on 22 March 2013, approved an extension to the indication of AdreView (Iobenguane I 123 Injection) from GE HealthCare for the scintigraphic assessment of Myocardial Sympathetic Innervation (cardiac nerve activity) to assist in the evaluation of patients with New York Heart Association (NYHA) Class II or Class III Heart Failure and Left Ventricular Ejection Fraction (LVEF) equal to or less than 35%.
The FDA initially approved AdreView in 2008 for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
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