Members of Congress are now asking the FDA to investigate a parent's claim that her 14-year-old son was treated with an experimental heart valve without proper consent. The valve eventually failed and had to be replaced. The hospital has said its heart team did nothing wrong. 

An expansion in access to mifepristone for telehealth patients is at risk before the Supreme Court. What does this mean for the FDA approvals process?

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.