FDA Grants Approval to Lantheus Medical Imaging’s Definity Label Update

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