Business Wire

On-X Life Technologies Reports CE Mark Approval to Sell Its Mechanical Aortic Heart Valve with an Expanded Labeling Claim: a Reduction in the Required Use of Blood Thinners

“This approval allows European clinicians to maintain patients on a lower dose of anticoagulant, which has been shown in a multicenter clinical trial (PROACT: Prospective On-X Anticoagulation Clinical ...
RAPS

QTc: FDA proposes labeling for heart drugs with heart rhythm risk

The US Food and Drug Administration (FDA) on Monday issued draft guidance offering recommendations for sponsors to include labeling information on QTc interval prolongation for certain heart drugs, ...
Nasdaq

FDA Approves Labeling Update for Abbott's HeartMate 3 Heart Pump for use in Pediatric Patients

ABBOTT PARK, Ill., Dec. 17, 2020 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved updated labeling for the company's HeartMate 3™ heart pump ...
FiercePharma

Delaware's Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

When it comes to heart failure medication, a labeling mix-up can have dire consequences. That's why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the ...