US FDA approves Akorn's injectable (PharmaBiz)
Akorn, Inc announced that the US Food and Drug Administration (FDA) have granted supplemental NDA approval for IC-Green for injection, USP. This approval is Akorn's first lyophilized product approval for manufacture in its Decatur, Illinois production facility.

Sunshine Heart Announces IDE Approval To Begin C-Pulse U.S. Clinical Feasibility Trial (Medical News Today)
Sunshine Heart (ASX: SHC), a global medical device company focused on innovative heart assist technologies, announced that it has received conditional approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its first U.S.

FDA beefs up its science staff (EETimes)
The Food and Drug Administration is bolstering its scientific capabilities in the face of accelerating technology change and market globalization, said the agency's newly appointed chief scientist in a keynote address at the Biomed Device conference.