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 ...

Last week, the FDA announced it was aware that Abiomed had sent a letter to affected customers recommending updated instructions for use for all Automated Impella Controllers (AIC). Abiomed identified ...

Impella heart pump upgraded to Class 2a in ACC/AHA treatment guideline for cardiogenic shock secondary to STEMI DANVERS, Mass., March 27, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, the global ...

PHILADELPHIA (KFSN) -- When a patient has a heart attack, doctors are working against the clock. Often their heart is too weak to pump enough blood. Cardiologists in major U.S. medical centers are ...

Abiomed has issued a recall alert after identifying a cybersecurity risk with its Automated Impella Controllers. In an Oct. 1 alert to customers, the manufacturer directed users to disable the ...