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 ...
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 ...
TCTMD

FDA Allows Claim About Oleic Acid’s Possible Heart Benefits on Labeling

The US Food and Drug Administration (FDA) will allow a new “qualified health claim” to be placed on the labels of oils with high levels of oleic acid, a monounsaturated fat, stating that consumption ...
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 ...