An FDA panel unanimously rejected J&J's V-Wave Ventura heart shunt, citing risks outweighing benefits despite safety data.

In nearly 60 years, heart transplantation has transformed from a daring vision to an established surgical procedure. Since ...

Life exists in surprising forms. Several creatures, including flatworms, jellyfish, and sponges, survive and thrive without a ...

The outside advisors analyzed the results of the RELIEVE-HF pivotal trial, which randomized 508 patients to either receive ...

The heart beats around 100,000 times a day, yet most people rarely think about how fast, or how efficiently it’s working, according to study published in the US. Heart rate isn’t just a number ...

Ventura's permanent interatrial shunt was designed to shunt blood from the left to right atrium to improve symptoms in ...

The FDA’s Circulatory System Devices Panel voted not to recommend approving use of an interatrial shunt to improve heart failure symptoms and prognosis.In a 0-15 vote, the committee determined risk ...

An FDA advisory panel gave a unanimous verdict for an interatrial shunt in heart failure: no way.

Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and ...

In nearly 60 years, heart transplantation has transformed from a daring vision to an established surgical procedure. Since the first adult heart transplant in the United States was performed at ...

J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the ...