There are new and revised warnings about the instructions for use of a certain type of heart pump that could lead to a risk of heart perforation, according to an alert issued by the pump's ...
The Abiomed Mobile Learning Lab visited the Springfield Regional Medical Center to educate its heart care team on the Impella device and give a hands-on simulation of implanting the device. The ...
The FDA typically requires post-approval studies for medical devices that receive a PMA, the FDA’s highest level of regulatory approval. FDA post-approval studies use high-quality prospective data to ...
WASHINGTON, D.C.—Johnson & Johnson MedTech’s Abiomed announced that its compressible, expandable heart pump has cleared a pivotal trial, and it’s now headed for FDA review in the coming months. The ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results