This is a Class I recall, which means the FDA believes these devices could cause a serious injury or death.

Conformal Medical developed its CLAAS technology to help patients with nonvalvular atrial fibrillation reduce their risk of stroke without the use of anticoagulants. Back in August, the company raised $32 million to help ramp up research on the device.

President Trump, 79, says he is still in excellent health. He also has no intention of cutting down on the high dose of aspirin he takes each day.

The New York-based imaging company is now focused on expanding sales for the cost-effective PET-CT system it developed with Neusoft Medical Systems.

The Sapien M3 transcatheter mitral valve replacement system is implanted using a transseptal approach. The device previously received CE mark approval in 2025.

Three patient deaths have been linked to connectivity issues with these devices. The FDA has classified this as a Class I recall.

Healthcare policies have rapidly evolved in recent years, and 2025 was no exception. From payment policies to physician shortages, ASE and other medical societies had plenty to fight for throughout the year.

Customers are urged to examine their inventory, quarantine any unused products and return them to the manufacturer. 

There is a risk that these catheters will fail to retain their shape during use, causing procedure delays and creating the risk of an adverse outcome. The FDA first warned users about the issue back in August.

The proposal, first announced by the Biden administration, was developed to improve patient data security. Those opposed argue that it would significantly increase costs and create a logistical nightmare for hospitals and health systems throughout the country.

Pediatric electrophysiology is an invaluable part of any healthcare system, and its importance is only growing as technologies continue to evolve. We spoke to Nicholas Von Bergen, MD, to learn more about where the specialty is headed in the years ahead.

Cardiologists often use the word “stable” when describing a heart failure patient who is recovering or showing signs of improvement. That word, however, could be giving patients a false sense of security—and it could even do harm to their long-term health. 

Sean Clifford filed the lawsuit Sept. 24, 2024, in the New York State Supreme Court, contending a radiologist failed to spot signs of a forthcoming stroke.   

Lantheus has signaled that the decision to sell its SPECT business will allow the company to focus more on growing its portfolio of PET radiodiagnostics and microbubbles.