FDA Review: Abiomed, Mallinckrodt, Aro and More

The FDA has a broad range of activities in the drug and medical device space. Here’s a look at the agency’s work this week.

September 16

Abiomed reported the FDA approved the on-label RECOVER IV trial in AMI cardiogenic shock patients. The agency also approved and closed Impella’s prospective AMI cardiogenic shock post-approval study, RECOVER III.