According to the agency, using these devices “may cause serious injuries or death.”

The newly cleared device is worn on the back of the arm and sends data directly to the user's smartphone. 

The new software was also added to the FDA's Tap Pilot program, an honor reserved for “high-quality, safe, effective and innovative medical devices."

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

Interventional cardiologists have been anticipating this news for quite some time. The device, the first of its kind, provides an alternative treatment option to repeat PCI or cardiac surgery for patients with coronary ISR.

The news represents yet another big regulatory approval for PFA technology in 2024. Could FDA approval be next for Biosense Webster?

Any devices that claim to make blood glucose measurements without piercing the user's skin are associated with a heightened risk of error, the agency said. 

ACC/STS National Cardiovascular Data Registry metrics reporting for TAVR is important for marketing and care quality, explains Patricia Keegan, NP, with the Emory Heart and Vascular Center.