To address this latest safety concern, the third in three months, the company is updating each device and then returning it to the customer.

The Department of Commerce is seeking more information about how current trade policies are impacting the U.S. medtech industry. The investigation could lead to the creation of new tariffs. Public comments are being accepted until Oct. 17, and the findings will be presented to President Donald Trump.

"There is already a deficit of doctors in the U.S., and this will make it worse," one cardiologist told Cardiovascular Business. Medical societies throughout the country seem to agree. 

There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that. 

The American College of Cardiology has shared new recommendations highlighting the protective benefits of a variety of vaccines. The new guidance also examines how to speak with patients who are hesitant to be vaccinated. 

The FDA-cleared device from Medtronic, which arrives pre-loaded on a single-use delivery system, is now set to launch in Europe.

SCAI says many children and adults living with congenital heart disease are being left behind by a payment system that does not adequately value their care.

Evinacumab-dgnb, sold by Regeneron under the brand name Evkeeza, can now be used to treat homozygous familial hypercholesterolemia in much younger patients.

Jamieson M. Bourque, MD, MHS, president-elect of the American Society of Nuclear Cardiology, shared the group's concerns with Cardiovascular Business. “This is going to have a highly negative impact," he said. 

The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated.