www.fdanews.com/articles/180315-fda-grants-approval-to-lantheus-medical-imagings-definity-label-update
FDA Grants Approval to Lantheus Medical Imaging’s Definity Label Update
February 2, 2017
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