New Class I recalls for more than 1M pacemakers | Q&A: What we know and don’t know about PFA | A key update for Medtronic

The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.

Peter Weiss, MD, a veteran electrophysiologist, sat down with Cardiovascular Business to discuss the ongoing rise of pulsed field ablation. While he's impressed with the technology, he says many questions remain about its long-term value. 

Going forward, Medtronic can include clinical evidence related to the treatment of ruptured abdominal aortic aneurysms in the device's labeling. This is the first time an EVAR system has received such an approval.

The FDA and Johnson & Johnson MedTech are telling customers to keep the devices in a secure environment until they can be disabled from all networks.

Adults with a history of CVD, type 2 diabetes and stroke were all associated with a lower dementia risk if they ate a whole food, plant-based diet. The study, published in JACC: Advances, was based on data from more than 71,000 U.K. Biobank participants. 

The device, manufactured by Contego Medical, was designed with rising procedure volumes and stroke risks in mind. 

As the United States continues to move toward quality-based care, ACOs need to rethink the way they attribute care to cardiologists and other members of the heart team. 

The document provides an in-depth look at the close relationship between inflammation and cardiovascular disease. "The time for taking action has now arrived," the authors wrote. 

The next-generation Watchman device is designed to better seal off complex LAA anatomy in a variety of LAA shapes and sizes.

"The key question isn't just whether a device works, but whether it makes procedures more efficient and provides physicians with a more predictable tool for treating patients with complex arterial disease," explained co-principal investigator Venita Chandra, MD, clinical professor of surgery at Stanford Health Care.

The toy company's magnetic resonance imaging play set was designed to help children get a better idea of what to expect before undergoing their exam.

The U.S. Department of Health and Human Services said the additional notices were sent in error. A union representing federal workers is challenging the firings, arguing that President Donald Trump lacks the authority to permanently eliminate jobs during a government shutdown.