The agency said Abiomed did not seek the necessary approvals for one Impella-related device and was slow to act on certain safety concerns. 

Dihydropyridines such as amlodipine have been the topic of some debate in recent months due to fears they lead to significant side effects. 

Lawrence Faucette, the second patient to ever receive a genetically modified pig heart, died on Oct. 30. “He can never be forgotten," his wife said in a statement. 

The subcutaneous administration of CBD could make a significant impact on patient outcomes, according to new findings presented at the Heart Failure Society of America's annual meeting in Cleveland.

The company hopes this new round of funding from private-equity investors will help its home-based care model flourish and reach more patients than ever before. 

The announcement came just weeks after an FDA subcommittee voted in favor of approval. 

The company can now begin the enrollment process for its PROACTIVE-HF 2 clinical trial, which will focus on treating patients with NYHA class II heart failure.