The Evolut FX+ TAVR system includes an updated diamond-shaped frame, which was made four times larger than previous models to offer improved coronary access. It was also designed to provide more space for operators to guide and maneuver the catheter during procedures.

Cardiologists now have two more tools to help them combat PAH, a rare vascular condition that often leads to heart failure.

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. 

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 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.

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.

Aprocitentan, sold under the brand name Tryvio, is approved for patients with high blood pressure who are already taking other antihypertensive drugs.