The American College of Radiology, American College of Emergency Physicians and American Society of Anesthesiologists want a court of appeals to uphold a recent ruling. 

The company already received CE mark approval for its new PFA offering and hopes it will soon be approved for sale in the United States.

The FDA has issued a Class I recall for Vyaire Medical respiratory support devices, saying use of older, defective devices could result in injury or death.

The news represents a meaningful policy shift for CMS. In the past, Medicare prescription drug plans have not covered medications designed to help patients lose weight.

Private payers eventually overturned more than half of denials, with the claims paid, but only after “multiple, costly rounds of provider appeals.” 

Elixir Medical's DynamX BTK System is an implantable device that supports BTK vessels after PCI or other interventions.

More than 100 patients have been seriously injured as a result of a significant safety concern. The Impella devices can still be used, according to the recall, if customers refer to Abiomed's new and revised instructions for use.

The inHeart models significantly reduce cardiac ablation surgery times.