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.

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

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

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

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.

This news follows similar announcements from Humana, Cigna and UnitedHealthcare; a majority of insured Americans can now be treated with these technologies and have the procedure covered by their provider. 

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.

Nick West, MD, Shockwave Medical's chief medical officer, detailed how the company is continuing to push IVL technologies forward. "We are leading the space ... we have no intention of giving up that position," he said.

Early evidence suggests CBD could help clinicians treat pericarditis, myocarditis and other significant heart conditions. Additional research is still required, however, including many more clinical trials.