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Home » FDA Grants Approval to Lantheus Medical Imaging’s Definity Label Update
FDA Grants Approval to Lantheus Medical Imaging’s Definity Label Update
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Massachusetts based–Lantheus Medical Imaging has been granted FDA approval for a label update for its Definity vial for injectable suspension.
The device label update removes from the U.S. prescribing information the contraindication statement related to use in patients with a known or suspected cardiac shunt.
The device is indicated for use in patients with suboptimal echocardiograms to outline the left ventricular endocardial border. — Cynthia Jessup
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