From cardiac ablation devices to OTC glucose sensors, explore how breakthrough medical technologies are disrupting ...
The FDA issued a notice warning that J&J MedTech‘s Abiomed unit recommended the removal of certain Automat Controllers (AICs) ...
DANVERS, Mass.--(BUSINESS WIRE)--The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart ...
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 ...
Abiomed updated warnings on more than 60,000 Impella Left Sided Heart Pumps because the device might cut the wall of the heart’s left ventricle, the FDA said March 21. After 129 serious injuries, ...
A new life-saving technology was used during a heartfelt reunion thanks to the world’s smallest heart pump, Impella, giving patients a second chance at life ...
DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (NASDAQ: ABMD) announces the United States Food and Drug Administration (FDA) has approved the company's investigational device exemption application to start ...
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 ...
A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert ...
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