The FDA ruled that this is a Class I recall due to the significant risks for patients. Customers are not required to return the devices, however. Inari Medical has provided updated warnings and recommendations that should be followed. 

The Digital Health Advisory Committee is tasked with providing perspective and recommendations on a wide variety of topics. These insights will then help the FDA draft new policies and make other important decisions.

The new expert consensus decision pathway replaces a similar document from 2019 and is to be used in conjunction with heart failure guidelines published in 2022 by the ACC, American Heart Association and Heart Failure Society of America.

Identical Cardiovalve systems were used to perform the procedures 18 months apart on a high-risk heart patient. 

V-Wave has gained considerable attention for its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and lungs of HFrEF patients.

The agency is gathering feedback on a proposal to double the amount hospitals are paid for coronary computed tomography angiography, with the comment period ending Sept. 9.

Cardiologist Dan Blumenthal, MD, MBA, explains how changes in Medicare payments will greatly impact cardiology in the years ahead. In just a few short years, the business side of cardiology could look substantially different than it does today. 

The new device from Huxley Medical offers care teams a way to monitor patients for signs of sleep apnea while also keeping a close eye on their heart health. 

Researchers tracked the long-term safety, effectiveness and durability of first-generation CoreValve devices in nearly 900 patients.

Regulators emphasized that these devices should not be used due to significant safety risks.