The FDA has received multiple reports of the devices, which are designed to be malleable, failing to retain their shape. The issue has been linked to three patient injuries so far, and customers are asked to return unused devices to the manufacturer. 

New ACC/AHA recommendations encourage clinicians to take a proactive approach when managing patients with elevated or high blood pressure. The inclusion of renal denervation in this document represents clear progress for a relatively new technology.

“It is your responsibility to be the patient’s advocate,” one expert explained. “We, as the nurses and technologists, have to speak up when we see something that isn’t right.”

Speaker issues are causing the devices to stop communicating with the user's CGM. Dozens of patient injuries have been reported, and the company is prepping a software update.

Hemodynamic valve deterioration after one year was more common in patients with a small aortic annulus. In fact, receiving a larger valve was linked to a “protective” quality that appeared to help keep the risk of such complications to a minimum.

Cardiology is number one in FDA Breakthrough Device designations at 218, the highest number out of all other clinical categories. This includes 16 new devices cleared in the past year.

Australia-based Artrya Limited says its AI-enabled Salix Coronary Plaque module offers near real-time, point-of-care CCTA assessment and management of coronary artery disease. 

The new drug, VTB-10, previously received the FDA's orphan drug designation in 2024.

More and more care teams are treating BAV stenosis with TAVR instead of surgical aortic valve replacement. Self-expanding and balloon-expandable valves appear to have their own benefits—as well as their own risks. 

"Eko is transforming how we detect cardiovascular disease—making cutting-edge, AI-powered tools accessible to frontline providers," said former U.S. Surgeon General Jerome Adams, MD.