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    Contrast agent for voiding ultrasonography earns FDA approval

    Bracco Diagnostics Inc. has received FDA approval for its contrast agent, Lumason, for use in ultrasonography of the urinary tract (voiding ultrasonography) for the evaluation of vesicoureteral reflux (VUR) in pediatric patients. The approval answers an unmet medical need for an effective imaging study to detect and follow-up VUR without exposing pediatric patients to potential harms of ionizing radiation, according to Bracco Diagnostics. The contrast agent is composed of gas-filled microspheres and is packaged in a three-part portable kit that does not require refrigeration or mechanical agitation. In 2015, the Centers for Medicare & Medicaid Services granted Lumason “pass-through” status for Lumason reimbursement under the Hospital Outpatient Prospective Payment System.

    For more information, visit http://imaging.bracco.com/us-en.

    Ben Schwartz
    Ben Schwartz is Associate Editor, Contemporary OB/GYN.

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